Corporate Quality Assurance Job at Syngene International Ltd
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.
Post : Associate Manager / Deputy Manager - Corporate Quality Assurance
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
• 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.
Candidate Profile
• M.Pharm / B.Pharm / M.Sc.
• 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.
• 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.
• Must demonstrate the commitment & dedication towards the work has been assigned and willing to take new challenges from management based on need.
Additional Information
Experience : 10-14 years
Qualification : .Pharm / B.Pharm / M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Corporate Quality Assurance
End Date : 30th December, 2020
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