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Contract Qa Specialist

Aequor
Aequor
3+ years
Not Disclosed
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.