Stanford Laboratories

3 days ago

Una, Gujarat, India Stanford Laboratories Pvt Ltd Full time

Job Title : Assistant General Manager (AGM)

Experience : 15-25 Years

Location : Una, Himachal Pradesh

Qualification : MSc/Post graduation degree in related field

Job description

Role & responsibilities :

- Lead the QC department (raw materials, in-process, finished products, stability, and microbiology) in line with cGMP and international quality standards.

- Assist in setting departmental objectives and ensure their alignment with the companys strategic quality goals.

- Act as a key quality contact for internal departments, auditors, and regulatory authorities.

- Ensure strict adherence to current Good Manufacturing Practices (cGMP), Good Laboratory

- Practices (GLP), and all applicable regulatory requirements (USFDA, MHRA, WHO-GMP, EU-GMP, etc.).

- Handle and support regulatory and customer audits and ensure timely closure of audit observations and CAPAs.

- Oversee OOS, OOT, deviation investigations, change control, and lab incident management.

- Supervise review and approval of analytical data, CoAs, protocols, and specifications.

- Ensure robust method validation, method transfer, and stability study protocols.

- Review and approve standard operating procedures (SOPs) for QC and laboratory systems.

- Monitor and improve laboratory efficiency and productivity.

- Ensure proper qualification, calibration, and maintenance of all laboratory instruments (e.g., HPLC, GC, UV-Vis, IR, Dissolution, KF, etc.).

- Monitor the performance of computerized systems and LIMS (Laboratory Information Management Systems).

- Lead and mentor a team of QC managers, executives, analysts, and microbiologists.

- Conduct performance reviews, training programs, and career development plans for team members.

- Promote a culture of accountability, compliance, and continuous improvement.

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