Senior Formulation Quality Control Manager

3 days ago

Ahmedabad, Gujarat, India beBeeCompliance Full time ₹ 1,75,90,000 - ₹ 2,51,15,000

We are seeking an experienced Quality Control Manager to oversee our day-to-day laboratory operations.

Key Responsibilities
  • Laboratory Operations:
    • Manage and supervise all activities in the laboratory, ensuring adherence to testing schedules and timelines.
    • Ensure compliance with regulatory requirements during all analytical and documentation activities.
    • Oversee sampling, testing, and release of raw materials, packaging materials, in-process samples, finished products, and stability samples.
    • Review and approve analytical results, test protocols, and validation reports.
  • Documentation & Compliance:
    • Ensure accurate documentation and maintenance of laboratory records, logbooks, and electronic systems.
    • Review and ensure compliance of all laboratory documentation as per regulatory requirements.
    • Prepare and review SOPs related to laboratory operations and ensure periodic training of staff.
  • Quality Management System:
    • Investigate and close QMS-related activities, including deviations, out-of-specifications (OOS), out-of-trend (OOT) results, laboratory incidents, and CAPAs.
    • Participate in internal and external audits, regulatory inspections, and implement corrective actions.
    • Maintain the laboratory in an inspection-ready state at all times.
  • Trend Analysis & Reporting:
    • Monitor and analyze quality trends across batches and stability studies.
    • Prepare periodic trend reports and present to senior management.
    • Identify areas of risk and recommend process improvements to enhance lab performance and compliance.
  • Team Leadership & Training:
    • Lead, train, and mentor a team of QC analysts and junior staff.
    • Ensure continual development of team skills and knowledge through structured training programs.
    • Promote a culture of continuous improvement, accountability, and quality excellence within the lab.

Bachelor's or Master's degree in Pharmacy, Chemistry, or related field is required. Minimum 7-10 years of experience in a Quality Control role within a pharmaceutical formulation environment, with at least 2-3 years in a managerial capacity is also required. In-depth understanding of GLP, GMP, and regulatory guidelines is essential.

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