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    Senior Associate, Quality Compliance

    Sun Pharma
    7+ years
    Not Disclosed
    Princeton Junction
    10 Nov. 28, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Position: Batch Certification & Compliance Specialist
    Company: Sun Pharmaceuticals (Taro)
    Location: Not specified

    Job Overview

    The Batch Certification & Compliance Specialist will oversee the review and certification of manufacturing batch records, packaging records, and QC lab documentation. This role ensures compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and ALCOA++ principles. The Specialist supports investigations of site deviations, cleaning validation, risk analysis, and compliance during regulatory audits. The role also involves preparation for FDA and other regulatory inspections, as well as implementing process improvements.

    Key Responsibilities

    • Batch Certification:
      • Review and certify manufacturing batch records, packaging records, QC lab records, and certificates of analysis/compliance.
      • Ensure all documentation complies with SOPs and regulatory requirements, including GMP, GDP, and ALCOA++ principles.
    • Deviation & Investigation Support:
      • Conduct reviews of site deviations, including planned/unplanned deviations, OOS/OOT investigations, and ensure adequate corrective and preventive actions.
    • Cleaning Validation & Risk Analysis:
      • Review cleaning validation documents, including plans, protocols, and reports.
      • Support quality risk analysis (e.g., FMEA) related to manufacturing processes and equipment cleaning.
    • Regulatory Compliance & Audits:
      • Ensure compliance with FDA and other regulatory requirements for product, process, equipment, and release procedures.
      • Support FDA readiness and provide assistance during internal and external audits, including inspections.
      • Conduct mock inspections and review documents to ensure audit readiness.
    • Process Improvements:
      • Identify compliance issues and support improvements to systems, procedures, and practices.
      • Support adherence to current SOPs and assist in updating them as needed.

    Physical Requirements:

    • Capable of bending, lifting, moving, and carrying up to approximately 10 pounds.
    • Ability to navigate between office, laboratory, and manufacturing environments.
    • Must wear personal protective equipment (PPE) such as respirators, safety glasses/goggles, and safety shoes as required.

    Work Environment:

    • Corporate Office Environment
    • Manufacturing/Production Environment
    • Laboratories
    • Warehouse Environment
    • Field Familiarity Environment

    Travel:

    • Up to 10% travel required.

    Education and Qualifications:

    • Minimum: Bachelor’s degree required.
    • Supporting seminars and courses in relevant areas are an asset.
    • Knowledge of GMPs and Good Documentation Practices (GDP) required.
    • Ability to work effectively in an international, multicultural matrix organization.
    • Software Proficiency: MS Office, TrackWise, LMS, Acrobat Reader, and other regulatory systems.
    • Language Proficiency: Intermediate level of English (B1+ CEFR).

    Experience:

    • Minimum of 7 years of experience in the pharmaceutical industry.
    • Experience in regulatory compliance, specifically within GMP and FDA-regulated environments.
    • Background in working in an international multicultural matrix organization is highly preferred.

    Compensation & Benefits:

    • Competitive salary with the possibility of an annual performance bonus.
    • Benefits include:
      • Medical, Dental, and Vision Coverage
      • Life Insurance
      • Disability Insurance
      • 401(k) Savings Plan with company match
      • Flexible Spending Accounts (FSA)
      • Employee Assistance Program (EAP)
      • Paid time off (vacation, sick leave, etc.)

    Notice to Agency and Search Firm Representatives:

    Sun Pharmaceuticals (Taro) does not accept unsolicited resumes from agencies and search firms. Any resumes submitted by a third-party agency without a valid signed agreement will become the property of Sun Pharmaceuticals, and no fee will be paid for those candidates.

    Disclaimer:
    This job description outlines the general nature of the responsibilities and qualifications of the position. Duties may change over time as required by the company. Sun Pharmaceuticals is an equal-opportunity employer, and discrimination on any basis is prohibited.

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