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Associate Manager -Quality Assurance

2+ years
Not Disclosed
10 Dec. 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, CPC Certified, 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

Role Summary
Pfizer is seeking a Quality Assurance Specialist to support its Pharm Sci Small Molecules Quality Operations (QO) department at the IIT Madras Research Park (IITMRP) in Chennai. This role focuses on performing Quality Assurance activities, including procedure administration, documentation, and records management, ensuring compliance with regulatory and internal standards. The ideal candidate will collaborate with key business lines, providing QA guidance, and fostering adherence to cGMP, ALCOA principles, and regulatory requirements.

Key Responsibilities

  • Procedure Administration: Manage procedural documents to meet commitments, business needs, or project timelines. Support the maintenance of the PharmSci Active Library and documentation systems.
  • Documentation Lifecycle: Partner with business lines to develop, implement, and manage documentation and records, ensuring compliance with ALCOA principles.
  • Compliance Oversight: Ensure adherence to cGMP requirements, including 21 CFR Part 11, 210, 211, and ICH guidelines, during lab operations and document reviews.
  • Inspection Support: Provide assistance for inspection readiness, internal audits, and regulatory inspections as needed.
  • Continuous Improvement: Suggest and execute improvements to enhance quality and efficiency across QA functions and business line procedures.
  • Collaboration and Culture: Promote a quality-focused culture and collaborate with teams to implement new initiatives and meet goals.
  • Documentation and Reporting: Utilize MS Office tools to manage documentation and prepare reports, including Excel and PowerPoint presentations.

Skills and Competencies

  • Strong knowledge of cGMP regulations and guidelines.
  • Familiarity with ALCOA and data integrity principles.
  • Excellent communication and interpersonal skills.
  • Self-motivated, disciplined, and results-driven attitude.
  • Ability to manage time effectively and work independently on assigned projects.
  • Proficiency in MS Office (Excel, Word, PowerPoint).

Qualifications

  • Education:
    • Master’s degree in Chemistry or Master’s in Pharmacy (QA or Chemistry).
  • Experience:
    • Relevant work experience in document management and procedure administration in the healthcare or pharmaceutical sector.

Work Location Assignment: Flexible, primarily based at IITMRP Chennai with onsite and remote work options.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.