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    Contract Qa Specialist

    Aequor
    3+ years
    Not Disclosed
    Somerset
    15 June 6, 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, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, 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

    Job Title: Contract QA Specialist, Validation / Qualification

    Company: Lupin Somerset

    Contract Details: Monday-Friday Work Week

    Role and Responsibilities

    The Contract QA Specialist, Validation / Qualification is responsible for providing quality oversight and ensuring that validation and qualification activities conducted at Lupin Somerset comply with FDA regulations, guidance, and recognized industry standards.

    Key Responsibilities:

    • Provide quality oversight for validation and qualification of:
      • Facilities and utilities
      • Equipment
      • Manufacturing processes
      • Packaging processes
      • Cleaning processes
      • Computer systems
    • Implement policies and procedures for validation and qualification systems consistent with FDA regulations, and corporate and site requirements.
    • Review and approve all protocols, plans, risk assessments, and reports related to validation and qualification of the aforementioned systems.
    • Review and approve applicable change controls, including impact assessments regarding changes to validated systems and processes.
    • Ensure that knowledge acquired during validation/qualification is incorporated into batch records and SOPs to maintain the validated state of processes throughout their lifecycle.
    • Collaborate with SMEs from various functional departments to ensure validation and qualification activities align with site and corporate SOPs.
    • Perform other duties as assigned by leadership.

    Minimum Education and Experience Requirements

    • Education:

      • Minimum: Bachelor’s degree in a scientific or technical field
      • Desired: Graduate degree

    • Experience:

      • Minimum of 3+ years of extensive experience in the pharmaceutical industry in Quality Assurance.
      • Cross-functional experience in engineering, technical operations, or product development is a plus.
      • Working knowledge of FDA and applicable non-US regulations, guidance, and industry standards related to pharmaceutical drug manufacturing.
      • Experience with process/method validation or equipment/facility qualification is highly desirable.

    • Skills:

      • Proficiency in using electronic Quality Management Systems, ERP systems, and MS Office applications.
      • Excellent analytical, coordination, and influential skills.
      • Ability to persuade cross-functional teams.

    Join Lupin Somerset and contribute to ensuring that our validation and qualification activities meet the highest quality standards.

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