Career as Assistant Manager - Quality Assurance & Compliance at Novartis healthcare

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Assistant Manager - Quality Assurance & Compliance

Job Description:
- To support Head QA & Compliance in implementing the applicable quality modules and the related SOPs at the home office as well to the contract manufacturing sites / distribution centres.
- To review the quality systems at the contract manufacturing sites and ware-houses in line with ‘ Novartis third party assessment standards’ and to ensure that the remediation plan is in place in case any gaps.
- Batch acceptance and SAP releases.
- Stability management .
- To monitor change controls, planned & unplanned deviations, corrective and preventive actions ( CAPA), compliances in trackwise .
- Annual product quality review.
- To prepare & issue updated Raw Material & Finished Product specifications.
- Return product management.
- Document management.
- To support Head QA in ,
- Market complaints investigation
- Product optimization projects
- Regulatory investigation
- Technology transfer project
- Investigation during product counterfeit incidences

Indicative Activities
- Ensure Quality Assurance & Compliance at contract manufacturing sites / warehouses & co-ordination
- Product stability management/APQR/Deviations /Change controls/Return product
- Technology transfer/Audits/ visits /Complaints handling
- Documentation/Training /reporting etc

Candidate Profile:
Chemistry / Pharmacy graduate / postgraduate
8 to 12 years hand on relevant experience in pharma industry
Professional Competencies (Knowledge, Skills and Abilities) :
- Ability to build rapport with a range of people at all levels
- Computer Literate with excellence in Ms Office and SAP

Additional Information:
Experience: 8-12 years
Location: Thane, India
Education: B.Pharm, M.Pharm, B.Sc, M.Sc - Chem
Job Type: Full Time
Employment Type: Permanent
Job ID: 79343BR

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