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    Manager Quality Systems & Compliance

    Abbott
    3+ years
    Not Disclosed
    Mumbai
    10 March 4, 2025
    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

    Manager – Quality Systems & Compliance

    Location: Mumbai, India
    Category: Quality

    Designation:

    Manager – Quality Systems & Compliance

    Reporting To:

    Head of Quality Assurance

    Main Purpose of Role:

    • Ensure the effective implementation and continuous improvement of Quality Systems within the commercial affiliate.
    • Oversee regulatory compliance, supplier qualification, internal audits, and CAPA management.
    • Support product action readiness, quality risk management, and compliance with regulatory requirements.

    Key Responsibilities:

    1. Quality Systems Review & Implementation (30%)

    • Implement and maintain Quality policies relevant to the commercial affiliate.
    • Review and update the Quality Manual in alignment with regulatory standards.
    • Assess the impact of applicable regulations on Quality Systems.
    • Ensure product action readiness, maintaining product action procedures as per compliance requirements.
    • Track and manage Quality Objectives to ensure Affiliate QA meets compliance benchmarks.
    • Support and monitor the Affiliate Quality Management Review process.
    • Ensure FSSAI license validity tracking for applicable sites.
    • Maintain an approved distributor list and ensure its regular review.

    2. Regulatory Compliance (20%)

    • Coordinate regulatory audits and inspections, ensuring timely follow-ups and compliance.
    • Implement Quality Metrics to drive improvements and ensure adherence to testing requirements.
    • Ensure compliance with Importation Testing requirements for India and Ex-India markets.
    • Maintain records and oversee Temporary Product Reassignment activities for Affiliate Quality.

    3. Purchasing Control (30%)

    • Ensure compliance with OACA-SUP requirements and relevant purchasing control procedures.
    • Conduct monthly governance meetings, identifying risks and ensuring timely action.
    • Develop and maintain a supplier audit schedule and re-evaluation plan.
    • Monitor supplier performance, ensuring compliance with set timelines.
    • Perform supplier qualification audits, re-evaluations, and Approved Supplier List (ASL) updates.
    • Review purchase orders and identify quality risks, taking necessary corrective actions.
    • Oversee Supplier Corrective Action Requests (SCARs), ensuring timely closure.

    4. Internal Audit & CAPA Management (20%)

    • Ensure compliance with internal audit procedures and OACA-CAPA guidelines.
    • Develop and implement the Internal Audit Program, ensuring stakeholder engagement.
    • Facilitate pre-audit preparations, document findings, and issue reports.
    • Upload audit findings into the SBM CAPA system as per requirements.
    • Track audit adherence and CAPA closure, conducting governance meetings for timely completion.
    • Support Root Cause Analysis (RCA) and CAPA review to ensure compliance.

    Experience & Key Skills Required:

    • Team Management: Experience in handling a team within Quality Assurance.
    • Regulatory Compliance: Expertise in managing regulatory and external audits.
    • Quality Systems Implementation: Strong background in HACCP and Quality Systems.
    • Audit Expertise: Internal Audit/Lead Auditor certification in ISO 9001, FSSC 22000/BRC.
    • Analytical & Communication Skills: Strong proficiency in Power BI, MS Excel, and data-driven decision-making.
    • Stakeholder Management: Ability to collaborate effectively with cross-functional teams.

    Preferred Certifications:

    • ISO, FSSC 22000, Quality Systems Certification
    • Lead Auditor for FSSC 22000

     

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    Bucharest |

    Makkah :

    Khulais | Jeddah | King Abdullah Economic City | Najran | Rabigh | Riyadh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |