Hetero Labs Looking for Assistant General Manager / Deputy General Manager – Quality Control (OSD) Formulations.
Education: B. Pharm / M. Pharm / M.Sc. / Ph.D
Experience: 17-24 years in Quality Control within the pharmaceutical (Formulations) industry
Key Responsibilities:
· Lead and oversee the Quality Control (QC) department, ensuring adherence to Quality Management Systems (QMS), Good Laboratory Practices (GLP), and regulatory compliance.
· Manage the testing and release of Raw Materials (RM), Packaging Materials (PM), Finished Products, and Stability samples, ensuring compliance with quality standards.
· Stay updated with current regulatory guidelines, including ICH, 21 CFR, and other relevant standards.
· Troubleshoot and maintain QC instruments, ensuring optimal performance and compliance with calibration standards.
· Monitor and ensure the laboratory’s compliance with regulatory requirements, maintaining Good Laboratory Practices.
· Review, approve, and implement Standard Operating Procedures (SOPs), specifications, test methods, and ensure Pharmacopoeia updates.
· Handle deviations, change controls, Out of Specification (OOS), Out of Trend (OOT) results, lab errors, incidents, and failures, implementing corrective and preventive actions.
· Ensure the identity, strength, purity, and safety of drug products through effective quality management systems.
· Approve or reject raw materials, in-process materials, finished products, stability samples, and packaging materials based on quality assessments.
· Prepare budgets and support the procurement of instruments, chemicals, and other consumables.
· Ensure timely qualification, calibration, and preventive maintenance (PPM) activities for QC instruments, maintaining accurate records.
· Identify and address issues within the QMS, implementing effective solutions.
· Allocate roles, responsibilities, and authorities within the QC department, fostering team development and providing necessary support.
· Manage internal, external, vendor, and regulatory audits, ensuring compliance and readiness.
· Plan and monitor testing activities for Analytical Method Validation (AMV), Analytical Method Transfer (AMT), and trial batch samples.
· Drive cost-saving initiatives and manage resources efficiently within the QC department.
Note: Candidates with experience solely in Active Pharmaceutical Ingredient (API) or unrelated sections may not be suitable for this role.
Interested candidates are invited to send their resumes with the subject line “Application for AGM/DGM – Quality Control” to Narendra.j@hetero.com.
