Senior Executive/ Junior Manager - Corporate Quality Assurance Job in Syngene International

JOB DESCRIPTION

Designation: Senior Executive / Junior 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:

• To participate in investigations as Corporate Investigation Team member for GMP- Formulation business (Non-Sterile) unit. (API Non sterile as a secondary responsible).
• To ensure adequacy and depth of investigations conducted in Formulation business unit.

Job Description:

Key Responsibilities:

• 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 & API (Non-Sterile).
• Responsible to participate and review investigations in GLP, GCP, Discovery, Development verticals as per respective procedures.
• Ensure the adequacy and depth of investigation within the threshold limit through scoring for all ongoing investigations.
• Ensure the adequacy and depth of investigation within the threshold limit which ever performed by Business Unit Quality Assurance through Surveillance checks.
• 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.
• Perform internal audits as a Subject Matter Expert for BUs, as and when required.
• Perform GEMBA walk and Safety interaction of the process area and play a role of SQDCE (Safety; Quality; Delivery; Compliance & Engagement) dashboard coordinator.
• Play a role of Training coordinator for the team.
• Any other responsibility as assigned by Head Corporate Investigation based on knowledge, experience and training.
• 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.

Educational Qualification: M. Pharm / B. Pharm / M.Sc.

Technical/functional Skills:

• Rich technical knowledge on quality assurance and amnufacturing process in GMP Formulation (Non-Sterile) is mandatory. API Non Sterile 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

Behavioral Skills:

Must demonstrate the commitment & dedication towards the work that 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.