Bal Pharma is a leading Indian Pharmaceutical Company with 25 years of experience, specialized in Prescription Drugs, Generic & OTC Products, Intravenous Infusion and Bulk Actives.
Post : ASSISTANT MANAGER – QC (API)
Location : Unit 2, Bommasandra (Bangalore)
Department : Quality Control (QC)
Experience : 10+ Years (API / Bulk Drugs)
Key Responsibilities
1. Active Pharmaceutical Ingredients (API)
• Perform and oversee QC testing of API samples.
• Ensure compliance with cGMP and applicable regulatory requirements.
2. Instruments Handling
• Operate and maintain HPLC and GC (both are important).
• Ensure proper system performance, calibration and troubleshooting.
3. Quality Systems & Documentation
• Work on QMS, method validation and method transfer.
• Follow ICH guidelines and pharmacopeial requirements.
• Review data and perform analysis, ensure data integrity.
4. Laboratory Operations & Compliance
• Oversee daily QC testing schedules and monitor turnaround times.
• Manage data integrity and chromatographic systems.
• Lead investigations for OOS, OOT and deviations with robust CAPA tracking.
5. Technical & Audit Oversight
• Supervise instrument qualification (IQ/OQ/PQ), calibration and maintenance (HPLC, GC, UV).
• Guide method validations/transfers and maintain audit readiness for regulatory inspections.
6. Team Leadership
• Mentor and train QC analysts.
• Enforce strict safety protocols and SOPs across the laboratory.
Candidate Profile
Education
• M.Sc. in Organic or Analytical Chemistry, or
• B.Pharm. / M.Pharm.
Experience
• 10+ years of hands-on QC experience in an API or bulk drug manufacturing environment with prior supervisory responsibility.
Key Skills
• HPLC & GC expertise (both important).
• Knowledge of pharmacopeias.
• HPLC parameter calculation.
• LIMS and QMS workflows.
• Strong root-cause analysis capabilities.
Kindly share your updated CV on
Email : placement@balpharma.com
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