Pharma QA Job at Syngene – 6 Months Exp Candidates Apply Online
About Syngene
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.
Designation: Executive – Quality Assurance
Job Location: Bangalore
Department: Corporate Quality Assurance
Requisition ID 55280 –
Key Responsibilities:
- Preparation and review of equipment, utility qualification relevant procedure and ensuring execution compliance as per approved SOP.
- Responsible for preparation of protocols and reports inline to site specific SOP for Biopharmaceuticals and Injectable facilities.
- Review of procedures, URS, impact assessment, Risk assessment, protocols & reports for qualification & validations for facility/Area, equipment & utilities in facilities.
- Coordinate the activities of qualification/validation with the stakeholder departments, ensuring the timely completion of projects and project milestones.
- Ensure QA validation oversight during FAT, commissioning and IQ, OQ & PQ as per qualification requirements & documentation.
- Review of Design documents and execution of IQ, OQ and PQ activity of the new facility/product/process critical equipment along with documentation in place in time as per defined procedure.
- Review of facility, Utility related drawings/layouts (for ex., pressure differential, AHU zoning, area classification, equipment layouts, piping drawings, isometric drawings etc.).
- Ensure QA validation oversight during periodic validation of critical process equipment, utilities such as HVAC systems water system and compressed air systems revalidations.
- Supporting to prepare VMP Calendar. Ensuring execution of Re-qualification activities as per VMP calendar tolerance.
- Support external client audits and regulatory inspections.
Educational Qualification:
M.Sc. / M. Pharm/ B. Pharm/ /B. Tech
Technical/Functional Skills:
- Technical knowledge in Biopharmaceuticals and Injectable.
- Should have minimum 1 years of work experience in Pharmaceutical Validation systems (Facilities, Utilities, Equipment, and Computerized Systems).
- Manufacturing Computerized System Validation (CSV)/ Process Control System deliverable preparation/review.
- QMS procedures.
- Should be knowledgeable on validation guidelines per different regulatory requirements and Industrial bodies, e.g., ICHQ2, ICH Q7, WHO, US FDA, EU guidelines, 21 CFR, ISPE, PDA, and PICS.
- Interpersonal skills to establish collaboration with cross-functional teams
- Establish good Interpersonal skills with cross-functional teams.
Experience:
0.6 to 3 Years + experience in the pharmaceutical Chemical API industry.
Behavioural Skills:
- Should have good communication skill and should be a good team player.
- Ability to work successfully in a dynamic, ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
Competencies
- Excellent written and verbal communication skills
- Good interpersonal skills
- Analytical strengths and high trouble shooting ability
Link to apply: Apply Online
Keywords: Pharma QA Job, Syngene, Executive – Quality Assurance, Bangalore, Corporate Quality Assurance, M.Sc., M. Pharm, B. Pharm, B. Tech, Biopharmaceuticals, Injectable, Pharmaceutical Validation, CSV, QMS, ICHQ2, ICH Q7, WHO, US FDA, EU guidelines, 21 CFR, ISPE, PDA, PICS. Pharma QA Job at Syngene – 6 Months Exp Candidates Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
