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 robust 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