Quality Compliance Manager

Truemeds · India

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)