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Quality - Qa Specialist

5+ years
Not Disclosed
10 July 16, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Quality Assurance Specialist

Company: TechDigital Corporation


Position Overview:

The Quality Assurance Specialist will provide Quality oversight to the Contract Manufacturing Organization (CMO), including on-site support for Quality Reviews and QA Shop Floor manufacturing. The role involves managing CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments, and CMO product release. The position may also cover other QA functions as needed.

Key Responsibilities:

  • Batch Production Records Oversight: Provide oversight for CMO Batch Production Records, review executed Batch Records, GMP documents, and prepare documentation for product release/disposition.
  • Documentation Management: Assist with Document Control and other QA functions; coordinate and assist in the timely review of documentation associated with manufacturing at the CMO site.
  • Regulatory Audits and Inspections: Prepare for FDA and other regulatory agency audits and inspections, provide daily summaries, and follow up on the completion of CAPAs from audit findings.
  • Guidance and Compliance: Offer guidance to CMO to ensure compliance with Client Quality standards; ensure all audit items are resolved, support the site for inspection, review Quality Events, and ensure timely completion of CAPAs from internal and external audits.
  • Issue Escalation: Escalate critical quality problems to Senior Management promptly.

Qualifications:

  • Educational Requirements: BS in Life Sciences or equivalent.
  • Experience:
    • Minimum of 5+ years of related experience within a pharmaceutical or biotechnology company.
    • Hands-on QA Site or ExM Operations/QA Systems experience, including supporting validations.
    • Additional experience in areas allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations, and manufacturing operations, auditing is preferred.
  • Skills:

    • Fluent in English.
    • Ability to coordinate Quality oversight and work with other site groups.
    • Proficient in reviewing Quality documents to ensure compliance with GMP, including batch records and logs.
    • Effective communicator to Management and line staff.
    • Capability to work with other manufacturing teams to implement business objectives.
    • Detail-oriented with the ability to quickly detect errors within documentation.