Dear Candidate,
We are hiring General Manager - QC Ambernath Plant
Key Responsibilities:
- Lead the overall QC function and 150+ member team, including AMV.
- Manage testing of RM, PM, in-process and finished products, including method validation, method transfer and stability studies.
- Ensure laboratory compliance with GMP, GLP, ICH, USFDA, MHRA and EU requirements.
- Solid expertise in HPLC, GC, UV, IR, DSC, PSD and other modern analytical techniques.
- Manage OOS, deviations, incidents, RCA, CAPA and laboratory QMS.
- Ensure calibration, qualification and preventive maintenance of laboratory instruments.
- Drive QC planning, sample management, laboratory productivity, KPIs and continuous improvement.
- Lead regulatory inspections/audits and ensure overall audit readiness.
- Collaborate with QA, RA, R&D;, AD, Supply Chain and other stakeholders.
Key Skills: QC Leadership, OSD, AMV, HPLC, GC, Method Validation, Method Transfer, Stability, OOS, CAPA, GMP, GLP, USFDA/EU Audits, LIMS, SAP & Empower.
Preferred: Strong experience as QC Head/Site QC Head in a USFDA-regulated pharmaceutical formulation facility.
Location: Ambernath
Experience: 20+ Years
Qualification: M.Sc / M.Pharm
Dosage Form: Solid Oral Dosage (Liquid/Nasal exposure is an added advantage)
Interested candidate can share their resume on "
[email protected]". Kindly do share and refer for better reach.
Thanks & Regards
Rahul Gupta
Assistant Manager - HR
Rubicon Research Ltd.
📌 General Manager (Mumbai)
🏢 Rubicon Research
📍 Mumbai