Senior Quality Assurance Lead

3 days ago

Cochin, Kerala, India beBeeSenior Full time ₹ 90,00,000 - ₹ 1,20,00,000

Job Title: Senior Quality Assurance Lead

Overview:

  • Lead quality assurance initiatives to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to develop and implement quality systems.

Responsibilities:

Key Responsibilities:
  • Quality Systems Development: Develop, implement, and maintain quality audit systems, ensuring adherence to Good Manufacturing Practice (GMP) regulations.
  • Vendor Qualification: Coordinate vendor qualification activities for raw materials, packing materials, and external testing laboratories.
  • Regulatory Compliance: Ensure all operations comply with cGMP requirements, including Qualified Person audits and regulatory inspections.
  • Quality Management System (QMS): Establish and maintain a robust QMS, managing change management, deviation management, incidents, complaint handling, and corrective actions.
  • Training and Guidance: Provide quality guidance to product development projects and programs, conducting data integrity internal audits, training, and review.
  • Validation Activities: Ensure all validation activities are performed according to approved protocols and requirements.
  • Operational Performance: Maintain and improve departmental operational performance to meet regulatory authorities, company SOPs, and customer requirements.
  • SOP Development: Develop and maintain departmental SOPs, ensuring regulatory compliance and fit-for-purpose operationally and commercially.
  • OOS/OOT Investigation: Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, documenting actions and corrective measures implemented.
Additional Responsibilities:
  • IPQA Activities: Monitor, review, and report on IPQA activities.
  • Document Preparation: Prepare, review, finalize, and submit documents to external customers and agencies as per regulatory requirements.
  • Validation Master Plan: Adhere to the validation master plan and schedule.
  • Control Sample Management: Manage control samples, stability, quality review meetings, documentation cell, lifetime documents archival program, artwork approval, shade card maintenance, label management, risk management, shredding, and pest control management.

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