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