Job Summary
We are looking for a Quality & Compliance - Senior Manager with experience in pharmaceutical manufacturing, pharmaceutical distribution, retail pharmacy, hospital quality assurance, or the pharmaceutical services industry . The ideal candidate should possess solid knowledge of the Drugs and Cosmetics Act & Rules, Medical Devices Rules, Magic Remedies Act & Rules , along with expertise in regulatory compliance, medication safety, quality assurance, and pharmaceutical operational processes.
Key Responsibilities
1. Catalogue Compliance
- Ensure drug catalogue accuracy, including Salt–Brand–SKU mapping .
- Classify medicines into OTC, Prescription, Restricted, Banned, and Cold Chain categories.
- Maintain LASA (Look-Alike Sound-Alike) tagging and substitution rules.
- Ensure all catalogue updates comply with applicable regulatory requirements.
2. Prescription Management
- Develop and maintain Standard Operating Procedures (SOPs) for prescription validation.
- Define guidelines for prescription authenticity, quantity limits,
refill eligibility, and expiry validation.
- Support technology-enabled prescription verification and maker-checker workflows.
- Collaborate with pharmacist teams for high-risk medicine reviews.
3. Doctor & Clinical Consultation Compliance
- Maintain compliance standards for doctor credential verification.
- Support prescription audit trails and consultation documentation.
- Establish clinical governance for prescription-linked workflows.
4. Dispensing & Fulfilment Compliance
- Ensure compliant pick-pack-dispatch processes.
- Oversee batch, expiry, cold-chain, and warehouse compliance.
- Monitor dispensing accuracy and medication safety.
- Implement final verification before order fulfilment.
5. Quality & Risk Management
- Drive Pharmacovigilance and Adverse Event Reporting processes.
- Manage Corrective and Preventive Actions (CAPA) and continuous quality improvement initiatives.
- Conduct int