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.
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Key Responsibilities
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1. Catalogue Compliance
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- Ensure drug catalogue accuracy, including Salt–Brand–SKU mapping .
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- Classify medicines into OTC, Prescription, Restricted, Banned, and Cold Chain categories.
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- Maintain LASA (Look-Alike Sound-Alike) tagging and substitution rules.
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- Ensure all catalogue updates comply with applicable regulatory requirements.
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2. Prescription Management
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- Develop and maintain Standard Operating Procedures (SOPs) for prescription validation.
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- Define guidelines for prescription authenticity, quantity limits, refill eligibility, and expiry validation.
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- Support technology-enabled prescription verification and maker-checker workflows.
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- Collaborate with pharmacist teams for high-risk medicine reviews.
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3. Doctor & Clinical Consultation Compliance
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- Maintain compliance standards for doctor credential verification.
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- Support prescription audit trails and consultation documentation.
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- Establish clinical governance for prescription-linked workflows.
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4. Dispensing & Fulfilment Compliance
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- Ensure compliant pick-pack-dispatch processes.
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- Oversee batch, expiry, cold-chain, and warehouse compliance.
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- Monitor dispensing accuracy and medication safety.
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- Implement final verification before order fulfilment.
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5. Quality & Risk Management
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- Drive Pharmacovigilance and Adverse Event Reporting processes.
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- Manage Corrective and Preventive Actions (CAPA) and continuous quality improvement initiatives.
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- Conduct internal audits and maintain inspection readiness.
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- Develop compliance dashboards and monitor key quality KPIs.
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Preferred Background
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Candidates with 4–7 years of experience in one or more of the following industries:
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- Pharmaceutical Manufacturing
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- Pharmaceutical Companies
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- Hospitals
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- Healthcare Organizations
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- Pharmacy Chains
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- Healthcare Service Providers
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Required Skills
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- Regulatory Compliance
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- Pharmaceutical Quality Assurance
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- Pharmacovigilance
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- Drug Safety
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- Adverse Event Reporting
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- Warehouse Compliance
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- Prescription SOP Development
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- Medication Safety
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- LASA (Look-Alike Sound-Alike) Management
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- CAPA (Corrective and Preventive Actions)
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- SOP Documentation
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- Audit & Inspection Readiness
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- Quality Management Systems (QMS)
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