Job Description

JOB DESCRIPTION
Designation: Junior Manager QMS - EGMP
Job Location: Bangalore
Department: QC
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 worldwide. 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 more than 4000- 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.
: Investigation of QMS Elements and Report Generation, Approval and co-ordination with QA and Maintaining a QMS/TAT/TPA matrix.

• Investigation of lab incident, deviations, OOS and OOT Addressing the client queries.
• To Manage a team of Analysts, creating / training them in compliance and managing Client projects independently.
• Responsible for Timely deliverables of projects.
• Responsible for ensuring the Team is aligned with Objectives and Goal of Early Phase GMP
• Responsible for handling of Client Audits, regulatory Audits and provide satisfactory responses to the concerned with in time frame.
• Responsible for ensuring all the analysts working within the team are trained/qualified.
• Responsible for continuous improvements within area of responsibilities.
• Ensuring Compliance & implementation of quality systems
• Ensure that all the current quality processes are followed.
• Ensure optimal utilization of Work hours & prioritization of activities to meet departmental commitments.
• To ensure that Good Documentation Practices and Good Laboratory Practices are being followed by the employees within the team. To ensure that the data generated with respect to its authenticity, correctness, completeness and other aspects of data integrity as per Data Integrity policy.
• Review of protocols/ Reports/ specification/ preventive maintenance documents /Observation data sheet/temperature mapping etc.
• Review of documents and records related to routine operations in Early Phase. Review of documents in EDMS and Track Wise
• Involving in Investigation and closure of OOS, OOT, Laboratory incidences, deviation, CAPA and Non-Conformity as applicable
• Review of QMS/Change Control in track wise and documents in EDMS as per requirement.
• Responsible for adherence of Lab safety requirements and Compliances as per Syngene policy and EHSS requirement.
• Responsible for ensuring all the procedural documents (SOP/IOP/GP) are prepared/updated as and when required.
• Interaction with client and Project team for the smooth functioning of project related activities.
• Closely monitoring the analytical activities and corresponding documentations as per the SOP, IOP, Protocols and specifications.
• Interaction with cross functional team in Early Phase department for timely completion of analytical activities.
• Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.
• Review of stability summary as per approved stability reports.
• Review of Observation data sheet / static data in LIMS.
• Responsible for taking any other job allocated by Head of the Department.

To ensure safety compliance as per Syngene policy and EHSS requirements.
Educational Qualification: M Sc / M Pharma (Analytical/General chemistry)
Technical/Functional Skills: * It should be well versed with the latest analytical techniques like HPLC/GC, KF/KFC, IR/UV, LC-MS, GC-MS, IC, ICP-OES/ICP-MS, DSC, TGA, etc...

• Being well-versed in the Chromeleon data management application and LIMS will be advantageous.

Experience: 3- 6 years
Behavioral Skills:

• Should be an adaptive learner.
• Should demonstrate effective Communication skills.
• Organization and ability to balance work and Life.
• Should possess good Time Management abilities.

Skills Required