The jobholder acts as a member of Third Party Operation's (TPO).

Jobholder closely interacts with the Team Lead and if required other departments such as Operations, Procurement, Supply Chain and Technical Services and provides complete support from quality perspective and conducting the effective investigation.

The position is to handle the Investigations associated with formulations that include various dosage forms of products for TPO. The market is primarily for US, EU, Canada and ROW.

The jobholder will be responsible for creating and maintaining standard operating procedures within the scope of TPO Organization And document management of the Quality documents.

Jobholder coordinates with the Team Leader and the QRM's and provide timely updates on the status of the investigations.

2. Job Purpose:

To manage the TPO Quality system requirements in accordance with quality standards and in compliance with the regulatory requirements.

This activity has the following aspects -

- Investigations like OOS, OOT, LIR, Complaints etc.

- QMS,

- CAPA

- Responsible to follow the Quality Management System of TPO organisation, which is relevant to job function.

This position is based at TPO Mumbai office and may involve very limited business travel on need basis.

Review the investigations related to TPO that are received from various CMO/Suppliers related to:-

- Deviations including manufacturing, laboratory, etc.

- LIRs

- OOS & OOT related to commercial batch releases

- OOS & OOT related to stability

- Complaints that includes investigations at the manufacturing site.

- Check for the adequacy of the investigations and coordinate with the team leader / Suppliers to get the complete investigation through QRMs

- On site investigations at CMO's as and when required to support business.

- Ensure proper investigation tools have been used to identify the root cause / probable causes.

- Ensure correct CAPA is provided by the CMO as per the root cause that was arrived from the investigation.

- Act as investigator in Trackwise system and route it to the Operational Quality Lead / respective QRM's for approval and disposition.

- Ensure that there are no overdue investigations in TrackWise.

- Maintain the KPI metrics related to Investigations in TrackWise.

- B. Pharm, / M. Pharm / M.Sc. (Science), B.S. Sciences.

- Pharmaceutical Sciences / Science.

Minimum 6-8 years of experience in pharmaceutical industry

- Knowledge on handling of investigations/deviations/OOS.

- Knowledge on cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment

- Experience of handling Operational Quality, QA/QC exposure and External / Contract manufacturing sites.

- Knowledge and working experience with USFDA / EU and other competent authority approved sites.

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