Syngene is looking to hire BBRC-Junior Manager, ARD QA .Interested and eligible candidates can send their resume.Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation…..The eligibility criteria as follows.
Vacancy details :
|Company Name||: Syngene|
|Department||: ARD QA|
|Designation||:BBRC-Junior Manager, ARD QA|
|No. of Vacancies :||:01|
|Qualification||:MSc /B. Pharm/M.Pharm|
|Salary||:Not Disclosed by Recruiter|
- Preparation and review of procedures such as SOPs, IOPs, GAM.
- Preparation and review of specifications for Raw materials, intermediates and final products.
- Preparation and review of validation protocols / Method reports.
- Co-ordination for approval of all the procedures / Protocols and reports by the respective department.
- Periodic updations of all procedures (Once in every two years or as and when required) as per the system requirements.
- Co-ordinate for training of new recruits till she / he completes departmental training.
- Initiation of change control, deviation and CAPA.
- Involving in investigation of Deviation and ensuring investigation is performed as per procedure.
- Involvement in providing compliance for audit observation along with Quality Assurance Department.
- Exposure to QMS systems using the software such as ‘TrackWise’, ‘EDMS’, SAP and ‘LMS’.
- Responsible for oversight of qualification and calibration of instruments.
- Checking data integrity & reliability in the quality control as per 21CFR 11
- Implementing and ensuring compliance to Quality control activities as per cGMP regulations, regulatory requirements
- Stock maintenance of adequate glassware, chemicals, instruments, analytical columns, reference standard and volumetric standards
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