Associate Manager / Deputy Manager - Corporate Quality Assurance Job in Syngene International Limited

JOB DESCRIPTION

Designation: Associate Manager / Deputy 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:

• Lead for Corporate Investigation team- Analytical division (Large molecules QC -Biologics & small molecules QC -API & Non-sterile formulation).
• Role involves in participating in investigations as a Corporate Investigation Team member for Quality Control - Biologics unit. Small molecules analytical investigations are secondary responsibility.
• Ensuring adequacy and depth of investigations conducted in Quality Control Large molecules (Biologics) & small molecules (API & Non-sterile formulation) as per established standards.
• Train the Business Unit Quality Assurance / Business Unit cross-functional team members on Investigation adequacy elements and the Investigation report's technical writeup.
• Handling Data Integrity incident investigations at Syngene and associated CAPA tracking for 100% on-time closure.

Job Description:

Key Responsibilities:

• Responsible for participating/ review the OOS, OOT, Critical, repeated, and major investigations of the Deviations and customer complaints etc. in the QC Biologics unit and support for small molecules analytical investigations.
• Responsible for participating 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 Analytical investigations (wherever CQA involves).
• Perform Surveillance checks on 'Business Unit Quality Assurance' led investigations for the adequacy and depth as per defined frequency.
• Responsible for monitoring the health of the Investigation process and strive for continuous improvement and play the role of Analytical Investigation subject matter expert for the site.
• Train the Business Unit Quality Assurance / Business Unit cross-functional team members on Investigation adequacy elements and the Investigation report's technical writeup.
• Responsible for participating in Data Integrity incident investigations at Syngene and accountable for tracking associated CAPAs for 100% on-time closure. Responsible for cross deployment of CAPAs to other Business units.
• Perform GEMBA walk and Safety interaction of the process area and play the role of SQDCE (Safety; Quality; Delivery; Compliance & Engagement) dashboard coordinator.
• Responsible for additional takeup tasks assigned by Head Corporate Investigation, based on knowledge, experience, and training on the task.
• Possess the knowledge and exposure to environment, health, and safety (EHS) practices.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.
  

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

Technical/Functional Skills:

• Rich technical knowledge must on analytical testing at a Quality control lab.
• Well versed (Experience) with Investigation and Root cause analysis skills is mandatory.
• Good negotiation skills are required during technical discussions with the peer group.
• Sound Technical writeup skills; Strong communication skills, and Presentation skills are a must.

Experience:

10 - 14 years of rich experience in Analytical quality assurance and Quality control in Biologics. Quality control small molecules API & Formulation (Non-Sterile) experience is add on.

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.