Process Safety Manager/Sr Manager - Healthcare/Pharma

Job Title : Manager/Sr. Manager - Process Safety

Reporting to : V.P EHS

Job Description:

- Planning & project tracking of scale up plan of New Chemical Entities (NCEs), Fist to File (FTF) and other Cost Reduction projects.

- To prepare, review, approve and distribute the instruction for the production of API or intermediate according to developed process / written procedure.

- To ensure implementation & maintaining plant as per cGMP & as per EHS guideline & SOP.

- To ensure validation protocols & reports are reviewed & approved.

- Hazop study, review for Process Safety & implementation of Hazop recommendation.

- Process Intensification using alternative/ new technologies.

- Review of process criticality and identifying bottlenecks of the process with respect to safety, quality, ease of operation and engineering aspect.

- Modifying process (if required) and transferring robust and scalable technology using Process Intensification.

- Inter departmental communication with Scientist, IP, RA, QA, QC and Production for concerns for Process Validations & scale up.

- Preparation of Schedule, managing proper information/ communication system within cross functional team (globally) and to keep management updated about progress and deviations.

- Preparation of Process Engineering Document, Safety document, Solvent recovery plan and Pilot report.

- Supporting CRD / pilot team during scale up & tech transfer of projects with respect to engineering assessment.

Harmeet Kaur
Synergy Consultants