Greetings from Syngene International..!!!
We are hiring following positions. Please find the details attached below.
Department: Corporate Quality Assurance
Designation: Senior Executive / Junior Manager
M.Pharm / B. Pharm / M.Sc
Experience: 06-08 years
Job Location: Bangalore
- 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.
- 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.
- 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.
- Must demonstrate the commitment & dedication towards the work that has been assigned and willing to take new challenges from management based on need.