Pharma QA Jobs Syngene – Apply For Executive Post
QA – GCP – Sr. Executive – QMS (54978)
Requisition ID 54978 – Posted 12/01/2023 – India
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.
Key Responsibilities:
Quality Management System (QMS):
- Responsible for the QMS of departments’ related to Phase I, BA / BE – Human Pharmacology Unit, Phase II to Phase IV Clinical Trials- Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Central Laboratory, Bioanalytical Research Laboratory; and other support departments of Syngene Clinical Development.
- Standard Operating Procedures’ (SOPs’): Issue of SOPs’, forms and log books to relevant departments; retrieval of obsolete SOPs’; control of master (original) SOPs’ – current as well as obsolete SOPs’. Any other responsibilities as indicated in relevant SOPs. Responsible for performing all the activities as EDMS coordinator.
- Change Control/ Deviation: Initiate relevant QMS item, review of the QMS item taken by the departments, follow up of the same for closure.
- Record control – ensure that all records are written legible. Control and maintain records in the QA department.
- Share best practices and ideas with fellow QA personnel.
- Analyze the root-cause for non-compliance / deviations; analyze trends observed (if any) and advice on resolving issues.
- Suggest improvement potential and best practices.
- Communicate lessons learnt to fellow QA personnel and apply the best practices across departments.
- Sponsor audits: Participate in Sponsor audits by preparing for the audit – liaising with the relevant department for preparation. Interact with Sponsor auditors – accompany and answer queries during the audit. Prepare and review corrective and preventive action plan and follow-up on the implementation of the same.
- Regulatory inspections: Participate in Regulatory inspections by preparing- liaising with the relevant department for the preparation; review documents, conduct mock-audits, guide personnel. Interact with Regulatory inspectors – accompany and answer queries during the audit. Prepare and review corrective and preventive action plan and follow-up on the implementation of the same.
- Training: Responsible for performing all the activities as Training coordinator/ LMS coordinator Identify training needs from audit experience and communicate to Head, QA and / or HR department. Inculcate the habit of self-development and participate in group discussions, seminars, workshops, etc. Drive education of document control across the organization. Train personnel in relevant guidelines and regulations.
- Management Review: Participate in management review meetings by preparing relevant presentations, suggesting best practices / improvements and implement the follow-up action indicated during the review.
- Good knowledge/exposure on handling Electronic document management system, Electronic Quality Management System (Trackwise), Learning Management System.
Archivist Responsibilities at Syngene International Limited-Clinical Development (In house archives/ Third-party archives):
- Ensure all activities related to Archives performed as per SOPs like Temperature & Humidity monitoring, Cleaning of Archival archives, any activity related to EHSS or Engineering & Maintenance.
- Ensure timely archival, retrieval and re-archival of documents (In-house as well as Third-party).
- Perform Mock-Recall for Third-party archives as per SOP.
- Receiving documents for archival from respective departmental study personnel and verify whether all documents are appropriately filed, labeled and numbered.
- Maintain all the Archives related logbooks.
- Communicating with Third-party archives for issues related to archives.
- To prepare & maintain documents related to Archives.
Educational Qualification: BE/ BCA/ BSc/ M.Sc / B. Pharm/ M. Pharm.
Technical/functional Skills:
Able to learn the functionalities of different softwares and a strong knowledge on the ISO standards and GCP requirements.
Experience: 03 to 06 years.
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. Ability to develop new ideas and creative solutions. Should be a focused employee.
Keywords: Pharma QA Jobs, Syngene, Executive Post, QA, GCP, Sr. Executive, QMS, Quality Management System, SOPs, Archivist, BE, BCA, BSc, M.Sc, B. Pharm, M. Pharm, ISO standards, GCP requirements. Pharma QA Jobs Syngene – Apply For Executive Post. 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.
