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 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 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)

📌 Quality Compliance Manager (Mumbai)
🏢 Truemeds
📍 Mumbai