Manager

Role description: This position is responsible for handling investigation function at the site. This position works closely with other organizational functions (like Quality Assurance, Quality Control, PDL, Manufacturing, R & D, and Corporate QA etc. ) for ensuring compliance to investigation activities at site.

Key deliverables
Supervise compliance of cGMP, GxP and any other applicable regulatory requirement, including EH&S requirements.
Complete self-training and monitor training of team members on the relevant SOPs.
Report any quality concern or suggestion for improvement to managers.
Execute and supervise all tasks and activities as per the applicable SOPs.
To lead and guide site investigation teams to investigate the reported OOS, repeat OOT, deviations and market complaints by working closely with site CFT and operating personnel, to arrive at appropriate RCA and CAPA.
To personally lead major/critical/repeat investigations and ensure proper closures.
To review and share weekly / monthly report of investigation with focus on key findings, repeats, open issues, CAPA effectiveness, learnings etc. , to the management.
To analyze historical data of investigations periodically, to derive trends emerging on any findings or any quality concerns or improvements and notify the management.
To mentor the SIT members for identified improvement areas.
To review and improve quality of investigations of other investigation members in terms of technical report writing skills as per format.
To conduct training programs on technical/ GMP related topics and ensure trainings of subordinates / team members.
To participate and support in Investigation management formats, matrices design and implementation.
To provide support to site during regulatory inspection or audits / Inspections conducted by local regulatory bodies / vendors / third parties, for related investigation.
To support the Quality Management Systems document closure - Deviations, OOS, OOT, LIR and market complaints, change control and CAPA, ensure upkeep of documents related to investigations and ensure compliance in QAMS as per requirement.
To perform any additional activity related to investigation as and when required.

Key customers
External
Corporate Quality Assurance
End user
Internal
Quality Assurance
Quality Control
Manufacturing
Engineering
Regulatory affairs
PDL
R & D

Customer Expectations
External
All regulatory / statutory compliance
Robust Investigation.
Internal
Participation in Investigation
Timely closure of investigation
RCA and CAPA evaluation

Education: B. Pharm / M/Pharm

10 to 15 Years