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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.
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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.
Position: Sr Executive – Quality Assurance
Location: Bangalore, Karnataka, India
Job Description:
Job Purpose:
This role involves in Analytical Quality Assurance activities pertaining to Quality Control Biologics (AQA activities of QC Biologics).
Key Responsibilities:
- Review, approval of RM/PM/Consumable reports, and release in SAP.
- Coordination in preparation and review of the QA SOPs in-line with current pharmaceutical guidelines.
- Responding to queries providing support to customer/regulatory on analytical related documents/requests as per the customer/regulatory requirement.
- Issuance of Analytical documents and document-related Raw Materials/Packing Materials/Consumables.
- Review of analytical test records, Analytical testing records, Analytical Method Validation, Analytical method transfer, protocol, and report as per written procedures
- Review of stability summary and stability reports generated by QC as per written procedures.
- Handling and being part of the investigations related to deviations, Laboratory incidents, Out of calibrations, Out of specifications, CAPA, and Out of trend.
- Handling & management of deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA identification.
- Handling, review, evaluation of change control, verification, and implementation of the Corrective and preventive action.
- Review of specifications and STPs for RM/PM/IP/FP of QC Biologics.
- Review of all laboratory analytical standard protocol, Reports & COAs.
- Review of Instrument operating procedures, IQ/OQ/PQ/DQ of all instruments of QC.
- To ensure the implementation of all EHSS norms to create a safe working environment.
- Training of employees on various aspects like good documentation practices and Good Laboratory Practices.
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
- Attend training on environment, health, and safety (EHS) measures imparted company.
Technical/Functional Skills:
- Should be good in Quality Control instrumentation.
- Should have knowledge in Analytical testing records, Analytical Method validation, Analytical method transfer
Behavioral Skills:
- 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 a team and flexible for working in shifts.
- Should be a focused employee.
Qualification: M.Sc
Experience: 3-6 Years
Salary: Negotiable
Contact Details:
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