Quality Assurance Officer- Lupin
Quality Assurance Officer- Lupin
Lupin
Job description
Looking for an opportunity in quality assurance, GMP compliance, and Pharmaceutical documentation? Lupin is hiring for the post of Officer - Quality Assurance at its Pune Biotech unit in Maharashtra.
Company Description
Lupin is an India-based pharmaceutical firm founded in 1968 with its headquarters in Mumbai. The company researches, develops and markets a comprehensive range of healthcare goods that include generic drugs, speciality pharmaceuticals. It serves markets globally through operations and products, with an emphasis on scientific discovery, manufacturing quality and improving access to healthcare.
Job Summary
The Officer - Quality Assurance position is located in Lupin’s Pune Biotech facility and is responsible for maintaining quality standards in drug substance (DS) manufacturing and warehouse operations. The selected candidate will assist in verifying compliance with Good Manufacturing Practices (GMP), regulatory standards and approved methods. The position also includes manufacture investigations, Corrective and Preventive Actions (CAPA), process validation, batch documentation, risk assessment and Annual Product Quality Review (APQR) preparation.
Key Responsibilities
Monitor drug substance manufacturing and warehouse activities for compliance with GMP guidelines, regulatory requirements, and approved processes.
Engagement in manufacturing investigations and contribution to the completion of Corrective and Preventive Actions (CAPA).
Develop and review risk assessment documentation and mitigation measures for any quality issues.
Ensure that process and cleaning validation activities are performed according established and authorized protocols.
Review the master documentation such research procedures, Batch Processing Records (BPR), Master Formula Records (MFR).
Review completed Batch Processing Records for batch release operations
Review batch dispatch records.
Liaise on data collection and Annual Product Quality Review (APQR) documentation preparation.
Prepare and review Standard Operating Procedures (SOPs) and other quality management system related documentation.
Review departmental SOPs to determine the SOPs meet applicable GMP criteria.
Educational Qualification
Candidates must possess Post graduate degree in Pharmacy.
Relevant work experience 1-3 years.
Skills Required
Strategic agility: Ability to adapt successfully to shifting objectives and workplace needs.
Innovation and creativity: Willingness to recognize improvements and think of realistic solutions to quality issues.
Customer-centricity: A focus on quality and the needs of stakeholders.
Responsibilities also include hands-on experience with GMP compliance, quality documentation, risk assessments, CAPA processes, validation protocols, batch record reviews, quality management systems.
Salary Structure
The projected compensation for a Quality Assurance post in India is ₹3-5 Lakhs per annum.
Career Development
This position can assist people in gaining hands-on expertise in pharmaceutical quality assurance, GMP compliance, validation, CAPA, batch release and quality documentation. This experience can help future development into senior quality assurance, quality systems or pharmaceutical manufacturing compliance roles.
How to Apply
Go to the our job portal and look for the Quality Assurance Officer listing.
Click the job post to see the full description, eligibility and hiring information.
Upload your resume and any materials needed in the application.
Submit your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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