Quality & Compliance - Senior Manager

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 strong 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 internal audits and maintain inspection readiness.
• Develop compliance dashboards and monitor key quality KPIs.

Preferred Background

Candidates with 4–7 years of experience in one or more of the following industries:

• Pharmaceutical Manufacturing
• Pharmaceutical Companies
• Hospitals
• Healthcare Organizations
• Pharmacy Chains
• Healthcare Service Providers

Required Skills

• Regulatory Compliance
• Pharmaceutical Quality Assurance
• Pharmacovigilance
• Drug Safety
• Adverse Event Reporting
• Warehouse Compliance
• Prescription SOP Development
• Medication Safety
• LASA (Look-Alike Sound-Alike) Management
• CAPA (Corrective and Preventive Actions)
• SOP Documentation
• Audit & Inspection Readiness
• Quality Management Systems (QMS)