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Quality And Compliance Consultant Resume

2.00 Rating

Salisbury, MarylanD

SUMMARY

  • Prepared, revised SOP's, raw material/product specifications and analytical methods. Approved quality agreements for vendors and contract manufacturers. Drafted documents for regulatory submissions across the world meeting regional regulatory requirements complying with standards and requirements. Reviewed, approved manufacturing, packaging and labelling batch records for API’s, drug products and medical devices for EU, US and Canada.
  • Accomplished excellent report writing and record keeping for documents, investigation files, change control requests, deviation reports and CAPA folders. Maintained and documented reports, records for internal auditing, regulatory inspections and client audits.
  • Conducted internal auditing of departments/divisions for compliance and internal requirements. Performed national and international on - site audits of vendors, suppliers, packaging/labelling manufacturers, warehouses, contract manufacturing organizations (CMO’s) and analytical laboratories ensuring quality of supplies and services. Prepared audit questionnaires and submitted reports to management for suggestions, improvement and future directions for internal auditing, approval of vendors, CMO’s and CRO’s.
  • Successfully hosted client, customer, regulatory, and vendor audits within every company ensuring comprehensive auditing practices were followed.
  • Assigned and encouraged team members for audit activities, report writing, post audit actions and training ensuring compliance.
  • Tracked vendors and suppliers list of raw materials, packaging supplies, production components and essential items. Ensured list of CMO’s and CRO’s for API and drug products manufactured.
  • Communicated with investigators and contract laboratories while conducting laboratory audits for results, analytical methods, and safety issues. Ensured instrument calibration was up to date with constant monitoring for calibration issues including tagging of equipment when out of calibration.

PROFESSIONAL EXPERIENCE

Confidential, SALISBURY, MARYLAND

QUALITY AND COMPLIANCE CONSULTANT

Responsibilities:

  • Review SOP’s, Protocols, batch records, validation reports, ensuring their compliance to regulations.
  • Suggest documents to have uniform formatting, workflows, sub-headings ensuring cGMP practices are implemented and followed in all areas.
  • Train personnel in cGMP’s, documentation, record keeping, auditing, regulatory and client inspection readiness with mock interviews and interactive group sessions.
  • Review change controls, CAPA’s, deviations, CoA’s for clarity /completeness for API’s and pharmaceuticals.
  • Ensure product stability program has protocols, stability indicating methods, sample withdrawal frequency enabling report writing and record keeping for API’s and finished pharmaceutical products.
  • Assess supplier qualification for raw material/API procurement norms, specifications and import rules.
  • Augmentation of quality leadership team for inspection readiness addressing issues prior to inspection.
  • Review and address compliance issues recording resolved matters readily available for presentation.
  • Ensure quality oversight on compliance matters for manufacturing, warehouse, quality assurance etc.

Confidential, CALIFORNIA

TECHNICAL AND VALIDATION LEAD - LABELING AND ADDRESS CHANGE PROJECT

Responsibilities:

  • Work with cross functional teams in aligning labeling and artwork requirements meeting milestones.
  • Collaborate and revise old artwork for SKU’s and software vendors to update new artwork.
  • Assist in Design control, verification, validation and transfer labeling artwork to appropriate work sites. Conduct weekly review meetings with stakeholders, share progress on projects, track self-utilization.
  • Assist stakeholders in regulatory affairs, submissions and submission deadlines identifying and verifying methods for batch processing of artwork FDA, EU, MDD, Canada and ROW quality requirements.
  • Familiar using wEbex for conference calls and SAP for material tracking and uploading respectively.

Confidential

SR. PROJECT MANAGER

Responsibilities:

  • Support implementation of PV and CAPA Management process across segments.
  • Provide CAPA process oversight of PV Deviations and CAPA’s associated with audit and inspection findings across Consumer and Pharma sectors.
  • Develop and approve compliance strategies to remediate deviations and observations from audits, inspections ensuring relevant CAPA’s are written reviewed and closed
  • Identified and executed needed actions with deliverables to support development for PV observations.
  • Liaise with business stakeholders through CAPA lifecycle management, review findings, suggesting recommendations for corrective action plans eliminating recurrences.
  • Track CAPA’s through completion and effectiveness monitoring including trending analysis.
  • Keep holistic view of common findings per PV audits, HA inspections and functional observations.

Confidential

QUALITY, VALIDATION AND REMEDIATION CONSULTANT

Responsibilities:

  • Perform method development for raw materials, finished pharmaceuticals and cosmetic products.
  • Responsible for remediation of earlier methods and improvement for better compliance.
  • Ensure methods are validated per protocols, regulations and document reports on completion.
  • Ensure training SOP’s, protocols and adverse event documents for all products. Ensure supplier metrics are understood for improvement. Assist in addressing questions raised by regulatory agencies.

Confidential

REGULATORY AND TRAINING CONSULTANT

Responsibilities:

  • Present training sessions amongst colleagues, local companies and recruiting agencies.
  • Topics covered quality assurance, compliance, good documentation practices, GMP’s, GDP’s, GLP’s, SOP writing, maintenance and review of batch records, internal /external auditing, stability programs, clean room operations, responding to regulatory inspections and other topics as requested.
  • Prepared Power Point slides (PPTs) on topics of interest in GMPs/GDPs/GLPs for US, EU and Health Canada and Leadership training for presentation to different audiences.

Confidential

SR. QUALITY ENGINEER

Responsibilities:

  • Responsible for assuring conformance to established procedures, requirements and standards through CAPA activities, including audit, inspection, and testing activities.
  • Interact with functional departments, suppliers, and experts outside Zimmer to effectively implement CAPA’s, Plan, lead, identify and organize project activities with realistic timelines.
  • Formulate procedures, specifications, and standards for Zimmer products and processes meeting and achieving customer specifications and regulatory requirements.
  • Provide leadership on CAPA projects; identify issues by Investigation, Implementation, and Verification of Effectiveness (VoE) including design, implementation, testing, support, reports and records. Work with CAPA Segment Manager developing and implementing CAPA plans.
  • Facilitate problem solving using FMEA with effective solutions. Identify critical personnel, gauges, procedures, and materials needed for completion of CAPAs, related exercises and administrative functions. Evaluate supplier risk management for supplies and services.
  • Ensure supplier quality issues are addressed, including metrics, non-conforming and unusable materials, regular complaints are responded timely. Escalate critical complaints to management for evaluation.
  • Complete appropriate regulatory forms for serious adverse events and submit to FDA keeping records, maintaining DMR’s event logs for good documentation and future reference.
  • Addressed Post marketing surveillance issues for medical devices for intended purposes. Monitored clinical studies including adverse events, healthcare personnel and patient complaints.

Confidential

SR. TECHNICAL DOCUMENTATION SPECIALIST

Responsibilities:

  • Change Control and Document Control - Major Tasks: Manage change control system adhering to procedure systems, handling clinical development change control tasks /change control requests.
  • Evaluate and/or approve change control documentation using scientific principles, analysis, meeting cGMP requirements with established timelines and compliance.
  • Assign stakeholders to review CCRs at organizational level. Confirm prospective changes do not conflict with process changes. Enter, review, query data in electronic systems for change control approval and closure. Back-up system administrator and oversight of product development.
  • Evaluate and approve supplier based change controls for correctness, improvement of supplies.
  • Maintained and monitored record keeping for Change Control, Reports and CAPA folders. Retrieve documents, records and files for internal auditing, regulatory and client audits.

Confidential

QUALITY ASSURANCE AND VALIDATION SPECIALIST

Responsibilities:

  • Deviation and CAPA management using Trackwise software for QC and contract laboratory results, OOS results and failure investigations.
  • Route investigations for review, discussion, assign stakeholders, document observations for inputs and interpretations, approval, authorization and closure.
  • Review procedures, protocols, reports and records for results, data accuracy and compliance while meeting regulatory requirements. Provide subject matter expert (SME) support where needed.
  • Present training sessions amongst colleagues, local companies and recruiting agencies.
  • Topics covered quality assurance, compliance, good documentation practices, GMP’s, GDP’s, GLP’s, maintenance and review of batch records, internal/external auditing, stability programs, clean room operations, regulatory inspections and other topics as requested.

Confidential

MANAGER - QUALITY ASSURANCE

Responsibilities:

  • The company manufactures OTC (sterile and non-sterile) pharmaceuticals, insect repellents and medical devices for contract manufacturers as CMO. Responsibilities were as below:
  • Conducted on-site audits for national and international locations of analytical laboratories, vendors, suppliers for raw materials, packaging components, label and contract manufacturers (CMO’s), warehouses within US and Canada per approved procedures in compliance with regulations. Authored audit ready questionnaires submitting reports to management to highlight progress and for future directions. Conduct supplier risk management and prepare reports.
  • Approved supplier qualification and programs for quality supplies of raw materials, packaging and production components including supplies for CMO’s with no issues for the company and vendors.
  • Ensured storage and monitoring for receiving, sampling and dispensing raw materials, packaging and production components to the shop floor and to contract manufacturers (CMO’s).
  • Achieved optimum labels and label inventory usage, yield and returns for medical device and pharmaceutical product labels with identification, traceability and accountability.
  • Reduced non-conformances from suppliers by working with purchasing (SQM, SCM), warehouse and engineering in eliminating repeat quality issues from the supply base.
  • Planned, scheduled, and conducted training programs for personnel in accordance with 21 CFR 210, 211, Part 11, CFR 820 and ISO 13485, GMP’s, QSR’s, quality activities, validation and stability studies.
  • Scheduled and organized internal audits, trained personnel for auditing, reviewing and reporting observations with management for progress and future directions.
  • Developed quality metrics for all functions using flow charts, control charts, fish bone diagrams relevant to each area. Assess risk of implementation and outcomes.
  • Document and review quality plans, record product performance meeting regulatory requirements of US, EU and Canada, in compliance with internal SOP’s for drug products, medical devices and (CMO’s).
  • Investigated vendor/customer complaints, adverse events, deviations, non-conformities, out of specification (OOS) results, including validation exercises. Document corrective and preventative actions (CAPA’s) for resolution using Trackwise software for US, EU and Canada.
  • Review batch records for manufactured drug products and medical devices including contract manufacturers (CMO’s). Ensured analytical, microbial and environmental certificates accompanied batch records for comprehensive review. Approved certificates of analysis (CoA’s) and approved certificates of compliance (CoC’s) prior to release, storage and distribution of finished drug products and medical devices to US, EU and Canada.
  • Supervised and approved packaging and labelling batch records for finished drug products and medical devices ensuring stability and retain samples were drawn per SOP’s and recorded.
  • Prepare annual product reviews (APR’s, PQR’s) for manufactured and marketed products for US, EU and Canada meeting regulatory criteria for each region.
  • Facilitate change control for documents/departmental functions in compliance with SOP’s and regulations.
  • Maintained vendor/customer complaint files and documents for pharmaceutical products, medical device products, ensuring responses as quickly as possible, including post market surveillance
  • Moderate product stability programs, protocols and approve reports per ICH regulations and climatic zones. Investigate OOS results and stability failures taking appropriate corrective actions.
  • Organized and interacted with regulatory inspectors from FDA, MHRA (UK), and Health Canada not receiving warning letter or citation resulting in savings of time, reworking and resources for the company. Communicated with regulatory agencies for observations and notifications.
  • Scheduled and facilitated management review meetings for progress of quality systems, presenting data, reports and quality metrics for suggestions, improvements and future directions.
  • Audited adverse event activities in coordination with QP’s. Audited client sites and submitted dossiers to regulatory agencies. Collaborate with peers for regulatory affairs for document submissions and records,
  • Address adverse events, maintain records and reports along with compliance documents with relevant information and ensure easy retrieval during client and regulatory audits.
  • Trained personnel in conducting pharmacovigilance audits, drafting reports including regulatory agency reporting for adverse events, while keeping track of event’s progress.

Confidential

MANAGER - QUALITY ASSURANCE

Responsibilities:

  • The company manufactured active pharmaceutical ingredients (API’s) as non-sterile products and controlled substances for cold and cough medications. Responsibilities included:
  • Scheduled and conducted internal audits of departments and functions for compliance with SOPs/GMPs.
  • Approve/qualify suppliers/vendors by auditing and reporting for national/international suppliers for API’s and contract manufacturing per ICH Q7A guidelines, GMP’s, SOP’s and customer requirements. Audited contract laboratories for method development and transfer. Approved analytical methods, ensured instrument compatibility and prepare COA’s per protocols.
  • Perform and document annual product reviews (APR’s) determining needed changes for processes, analytical methods, stability programs, vendor rating and performance and revalidation exercises.
  • Develop drug master files (DMF’s) while assisting others in completion of DMF’s. Ensure suppliers are kept informed of all the details and ensure total confidentiality of all transactions
  • Investigate customer complaints, abnormal yields and OOS test results, analytical discrepancies, processing deviations, stability failures and non-conformances. Address and resolve supplier corrective and preventive actions to the satisfaction of management, suppliers and CMO’s.
  • Review, approve, author SOPs, policies and test protocols for compliance per ICH Q7A and GMP’s.
  • Review, approve validation/clinical protocols, reports, manufacturing batch records and certificates of analysis (CoA’s) prior to release and distribution of finished API’s.
  • Conducted clinical studies for substance abuse of controlled drugs for misuse, abuse and improper use among male/female subjects achieving excellent rate of success and extended studies to wider groups.
  • Scheduled and administered cGMP’s, GLP’s, GCP’s and quality systems training programs to company personnel ensuring understanding of issues with general quiz programs.
  • Monitor product stability programs for manufactured API’s investigating failures per ICH guidelines.
  • Interact with FDA, DEA, OSHA and EPA, conduct meetings, ensuring availability of documents, records, and reports, respond to queries when needed.
  • Ensure handling and disposal of controlled substances per DEA norms. Maintain records/reports, providing assistance for DEA audits, internal reviews of materials, samples, products and storage system

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