Job title: Senior Executive – Quality Assurance – GMP – Chemical Development
Company: Syngene International Limited
Job description: Designation: Senior Executive
Job Location: Bangalore
Department: Quality Assurance
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.
- Responsible for Preparation, review and revision of QA SOPs using the Software EDMS.
- Handling of Change control, Deviation and CAPA Systems for small molecules of GMP functions through Track wise .
- Handling Document management System.
- Review and approval of master Specifications’, ODSs’.
- To support during client audits, regulatory audits, vendor audits.
- Responsible to ensure the Effective Review of Analytical and Cleaning Method validation, Process validation, Excel validations, Forced degradations – protocols and reports,
- Responsible to ensure Quality management systems are followed in the Laboratory.
- Responsible for ensuring log books are issued which are required for usage in Laboratory.
- Responsible to ensure certificate of analysis are Review and approved of Raw Material, Packing material, Primary reference standard/ Working standard, Intermediate & Finished product.
- Review & approval of specifications for FFP/PM/RM/IP/FP/INT.
- Responsible to ensure release of raw material, packaging material, intermediate & finished product batches in LIMS/SAP.
- Responsible to ensure review & approval of analytical calibrations report in LIMS.
- Responsible to ensure Review & approval of working/Lab/impurity/GC standards/ thawing time of standards COA and reports.
- Ensuring method transfer activity is followed as per procedure.
- Ensuring of conducting regular GMP rounds at Quality Control Laboratory.
- Ensuring CAPA s are initiated to avoid occurrence and effectively implemented.
- Issuance of the documents (annexures, ODS, Calibration sheets, log sheets etc.,)
- Responsible to ensure the documents related to Analytical-QC are reviewed and approved. Responding to queries providing support to customer/regulatory on analytical related documents/requests as per the customer/regulatory requirement.
- Responsible Quality control activities, Monitoring & controlling the stability programs, DI compliance, OOS & OOT investigation, day to day compliance of QC with specific Quality guidelines. Well versed with preparation, review and approval of QC related documentation.
- M.Sc., / M. Pharm with minimum 6 + years of working experience with Pharmaceutical / Life science.
- Hands on Experience in Track wise and EDMS.
- 6 to 8 years
- Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
- Good speaking-listening-writing skills, attention to details, proactive self-starter.
- Ability to work successfully in a dynamic, ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Ability to develop new ideas and creative solutions.
- Should able to work in team and flexible for working in shifts.
- Should be a focused employee.
Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities ,
Location: Bangalore, Karnataka
Job date: Tue, 04 Jan 2022 08:50:19 GMT
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