Senior Quality Assurance Manager

15 hours ago

Gandhinagar, Gujarat, India beBeeQuality Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Title: Senior Quality Assurance Manager

As a key member of our quality assurance team, you will play a critical role in ensuring the highest standards of product quality and compliance with regulatory requirements.

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  • Key Responsibilities:
    • Develop, implement, maintain, and improve Quality audit, maintain GMP quality systems and Behavioural GMP aspects;
    • Coordinate and perform all vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories and any other outsourced activities, Internal Audits, compliance audits;
    • Responsible for coordination and finalization for Qualified Person audits and Regulatory Inspections;
    • Responsible for CAPA close out for all audits and inspections;
    • Develop, maintain and improve a GMP compliant document control system;
    • Establish a robust Quality Management System (QMS) to manage and implement change management, Deviation management, Incidents, complaint handling and CAPA management;
    • Responsible for All GMP trainings and Quality training programme;
    • Oversee investigations of all non-conformances (deviations, complaint etc.);
    • Responsible for handling Product Recall;
    • Create and maintain system to implement requirements of ICH Q8 (QBD), ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).
  • Requirements:
    • Well versed with requirements of Injectable products, facility requirements and Media fill requirements;
    • Responsible for Technology Transfer documents compile necessary records and smooth transmission to meet and comply to regulatory requirements;
    • Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost;
    • Ensure development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being - fit for purpose operationally and commercially;
    • Ensure that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies;
    • Ensure that there is a self-inspection programme in place to meet the requirements of EU GMP/PICS/TG/MHRA etc.
  • Benefits:
    • Comprehensive benefits package including health insurance, retirement plan, and paid time off;
    • Opportunities for career growth and professional development;
    • A dynamic and supportive work environment.
  • What We Offer:
    • Competitive salary and bonus structure;
    • Stock options and equity participation;
    • A collaborative and inclusive work culture.

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