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    Site Quality Head

    Sun Pharma
    20+ years
    Not Disclosed
    India Remote
    10 Feb. 11, 2025
    Job Description
    Job Type: Full Time Remote 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

    Job Title: Site Quality Head

    POSITION SUMMARY:

    The Site Quality Head is accountable for ensuring the supply of high-quality, GMP-compliant products. This role involves defining the operational strategy for quality system management at the site and finalizing site quality assurance (QA) and quality control (QC) goals, objectives, and strategies in alignment with Sun Pharma’s compliance, product quality management objectives, and regulatory requirements.

    The Site Quality Head provides leadership and direction to ensure the achievement of all site accountabilities for QA, QC, and stability. The incumbent will proactively assess quality issues at the site, ensure compliance with QA/QC regulatory requirements in manufacturing operations, and track and drive quality metrics with site manufacturing teams. The role also ensures readiness for regulatory inspections and internal audits.

    KEY RESPONSIBILITIES:

    Quality Assurance & Control:

    • Assess and resolve quality issues at the site, ensuring compliance with QA/QC regulatory requirements.
    • Track quality metrics with site manufacturing and drive improvements.
    • Design, implement, and ensure compliance with all quality-related SOPs, policies, standards, and quality systems.
    • Monitor market complaints, failures, and deviations. Ensure corrective and preventive actions (CAPA) are implemented on time.
    • Ensure compliance with regulatory requirements for product, process, and release procedures.

    Leadership & Team Management:

    • Provide leadership and direction to ensure site accountabilities for QA, QC, and stability are met.
    • Manage resources, including manpower, to maintain compliance with GxP requirements.
    • Design and execute continuous improvement initiatives to enhance compliance, drive efficiencies, and reduce costs.
    • Ensure the availability of necessary resources to maintain the site’s quality and compliance.
    • Facilitate harmonization and implementation of global quality standards and systems at the site.

    Regulatory Readiness:

    • Ensure the site is always ready for regulatory agency inspections and internal audits.
    • Implement corrective actions as required from audit findings.
    • Monitor industry trends and issues, identifying opportunities to improve site quality management and processes.

    Budgeting & Financial Management:

    • Prepare site quality revenue and capital budgets, as well as headcount projections.
    • Track and manage expenditures and headcount to ensure alignment with the budget over the fiscal year.

    Collaboration & Compliance:

    • Ensure smooth collaboration with other Sun Pharma sites and functions to leverage synergies and align quality practices.
    • Ensure the release of safe and effective drug products in accordance with cGMP and regulatory commitments.
    • Follow the Environmental, Health, and Safety (EHS) policy, laboratory SOPs, and maintain compliance with GMP requirements.

    MINIMUM EDUCATION & EXPERIENCE REQUIREMENTS:

    Educational Qualification:

    • Required: Science or Pharmacy Graduate or equivalent

    Experience:

    • Minimum Experience: 20+ years in pharmaceutical quality management leadership roles, with preference for candidates currently in a similar role.

    If you have significant experience in quality management within the pharmaceutical industry and a track record of leading quality assurance and control initiatives at a site level, apply now to join our team!

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    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |