Assistant Manager / Executive - Quality Control post vacant in Mylan Laboratories
Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit www.mylanlabs.in
Job Number: Assistant Manager / Execuitve- Quality Control-Unit-3-JDM
Areas of Responsibility
The Senior Team Member - Quality Control will have the following key responsibilities:
- Plan and analyse day to day samples of raw materials/ packaging material/ in-process/ finished products/ stability; Validate samples as per specifications; Evaluate cleaning samples testing methods; Execute analytical method transfers
- Plan and execute Laboratory instruments calibrations; Execute Preventive maintenance program for laboratory instruments; Manage and adhere to working standard and qualification as per requirement; Review and manage external standards records
- Handle inventory management in the laboratory; Distribute daily work activities to team members as per samples plan; Review analytical data after completion of analysis; Investigate laboratory incidents, OOS, OOTs etc.; Involve in resolution of laboratory issues / concerns with respect to methods, inter-departmental issues, regulatory, market complaints
- Review and follow on-line documentation practices; Participate in internal audits; Identify the gaps in procedures and up-date the team lead; Adhere to test procedures and SOPs
- Education: Post graduate in chemistry / pharmacy
- Experience: Minimum 6 years of experience in pharmaceutical industry
- Knowledge of Analytical Techniques.
- Knowledge of Calibration and qualification requirements for Lab instruments.
- Knowledge on instrument trouble shooting.
- Knowledge of relevant regulatory guidelines and handling of regulatory Audits
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