Sun Pharmaceutical Industries Limited is taking this opportunity to balance employment and the medications to the world. We are hereby inviting candidates who are interested to join India's No. 1 company in Pharmaceutical sector.
Post : Senior Manager, Analytical Research - QA
Job Description
1. Provide leadership and direction to group to ensure achievement of CMC Quality accountabilities and responsibilities.
2. To provide guidance for robust analytical method development to ensure decrease in method failures.
3. To support on pharmacopoeia updates and new regulations for analytical methods to ensure continual improvement of the quality system.
4. To lead, manage and motivate people with a variety of skill sets. Strong organizational, interpersonal and communication skills are essential. Use excellent negotiation and interpersonal skills to communicate effectively with all levels of the organization and external stakeholders.
5. To ensure the complaint of Analytical Method Development activities related to Chemical Entities, API, Drug Product Formulations.
6. To assure that Method Validation / Method Qualification / Method Transfer data are reviewed adequately within time and verify scientific rigor, adequacy, and completeness. Take active participation in the trouble shooting.
7. Developing procedures / system to ensure compliance of R&D function.
8. To provide technical support for Plant Analytical Trouble Shooting investigation and regulatory query response.
9. Expertise in Quality Risk Management Method & Tools (Like Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Heatmap, Fishbone etc).
10. Expertise in extractable and leachable study.
Skills
• Understanding of CGMP required.
• Good Communication skill with good convincing power.
• To have critical thinking approach & deep evaluation on subject on time to support leadership to derive right and faster decision to meet organisation’s need.
• Excellent Managerial Skill and positive approach
• To understand and interpret the data of sophisticated analytical instruments like HPLC, GC, IC, SEM, TEM, Auto-titrator, UV spectrophotometer, FTIR, Particle size analyzer, ICP-MS, LC-MS, GC-MS, HRMS, XRD, DSC, Dissolution, Viscometer, Rheometer etc.
• Prioritization according business requirement.
Additional Information
Experience : 15 -25 years
Qualification : M.Sc/ M.Pharm
Location : Vadodara
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Analytical Research - QA
End Date : 25th October 2024
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