Team Lead - Process Engineering - API - CRDMO

Sai Life Sciences Ltd

0 years

0 Lacs

hyderabad telangana india

Posted:1 month ago| Platform:

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Skills Required

engineering api planning optimization calculations reports assessment technology manufacturing support evaluation data audits risk report software initiation

Work Mode

On-site

Job Type

Full Time

Job Description

Mentor team member for properly planning the critical operations to study critical process parameters in view of scale up and pilot experiments with clear objectives.
Be instrumental in preparation of Process engineering protocols and evaluate it for improvements. Ensure that team is consistently following the protocols.
Discuss the processes at the start of lab optimization work and participate in process review or discussion before execution in the plant.
Review and provide feedback to Process Engineers on Process engineering calculations, BPR, P&ID and Investigation, Campaign and Validation reports for its completeness and correctness.
Ensure that PE comply walkthrough (facility assessment), Formal technology transfer to the manufacturing team, closing of QRM and QMS documents and monitor first successful batch and provide necessary support to manufacturing team.
Review RFPs and ensure that PE submits to PPIC for further evaluation within three days of allotment/getting the process data.
Understanding team needs such as professional trainings, personal aspirations and other developmental skills and plan the trainings. Put efforts to increase the motivational level of team and sense of belongingness. Appraising the team dynamics to HOD and HR for necessary actions. Work closely with HR for building the team.
Clearly defining the roles, responsibilities and expectations from the team. Review the team member performance against the same and provide constructive feedback for improvement.
Plan constructive weekly project review meetings and monitors the progress closely by clear-cut action plans and responsibilities of PEs.
Participate in client audits and represent the department upon delegation from HOD.
Handling of Risk assessment, Batch Production Record, Batch packing Record, Technical package, Justification report and any other QMS documents approval procedure in GMP-Pro software.
Handling of Change control, Planned Changes, Deviations, Initiation approval procedure in GMP-Pro software.

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