Sr. Executive/ Jr. Manager

Job Description

Designation: Sr. Executive / Jr. Manager Job Location: Bangalore Department: Corporate Quality Assurance 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. Job Purpose: Responsible to participate in investigations as Corporate Investigation Team member for GMP- Formulation business (Non-Sterile) unit. (Microbiology as a secondary responsible).Responsible to ensure adequacy and depth of investigations conducted in Formulation business unit & Microbiology department. Key Responsibilities:
1. Responsible to participate/ review the critical investigations, repeated and major investigations (as and when required) pertaining to the Deviations and customer complaints, OOS, OOT etc. in GMP verticals i.e. Formulations (Non-Sterile). & Microbiology
2. Responsible to participate and review investigations in GLP, GCP, Discovery, Development verticals as per respective procedures.
3. Ensure the adequacy and depth of investigation within the threshold limit through scoring for all ongoing investigations.
4. Ensure the adequacy and depth of investigation within the threshold limit, which ever performed by Operating Unit Quality Assurance (OUQA) through Surveillance checks.
5. Train the OU/ OUQA cross-functional team members on Investigation adequacy elements and the Investigation reports technical writeup.
6. Responsible to monitor the health of Investigation process and strive for the continuous improvement and play a role of subject matter expert for the site.
7. Perform internal audits as a Subject Matter Expert for OUs, as and when required.
8. Perform GEMBA walk and Safety interaction of the process area and play a role of SQDEC (Safety; Quality; Delivery; Engagement & Compliance) dashboard coordinator.
9. Play a role of Training coordinator for the team.
10. Any other responsibility as assigned by Head Corporate Investigation based on knowledge, experience and training.
Educational Qualification: M.Pharm / B.Pharm / M.Sc. T echnical/functional Skills: Rich technical knowledge on quality assurance, manufacturing process & Analytical in GMP Formulation (Non-Sterile) is mandatory. Microbiology experience is add on (but not mandatory).Well versed (Experience) with Investigation and Root cause analysis skills is mandatory.Good Technical write up skills; Communication skills and Presentation skills are must. Experience: 06-08 years and rich experience in quality assurance, manufacturing process & Analytical in GMP Formulation (Non-Sterile). Microbiology experience is add on (but not mandatory). Behavioral Skills: Must demonstrate the commitment & dedication towards the work has been assigned and willing to take new challenges from management based on need. 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.,

Keyskills :
root causecontinuous improvement facilitationroot cause analysis