28/06 Nayna Khandare
Senior Account Lead at Randstad India

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Plant Manager - GMP Pharma Production (10-20 yrs)

Gujarat/Vapi Job Code: 714431

Job Responsibility:

The GMP manager manages and coordinates GMP regulated activities from initial stage of development, design, document control and record keeping for GMP regulated plant and product. The manager is also responsible for ensuring consistent GMP compliance with regards to FDA and other related worldwide health authority regulations/guidelines; site SOPs, protocols and industry standards through domestic and international audit process. The manager would also conduct training programs for compliance and audit related topic.

Additionally the said position will take care of the process technology areas as per production load at GMP plant

The Process technologist is responsible for scaling up chemical process from lab scale to pilot scale and further scales up to establish process in manufacturing plant for product commercialization. During this progression, material balance, energy balance, safety analysis, automation required for risk mitigation, equipment selection, plant layout, material of construction applicable for the process, effluent and environment impact, process economics are established. The manager coordinates for above related activities with all concerned department to ensure successful commercialization of the product meeting all national and international requirement.

WHAT YOU DO:

- Provide assistance to entire team for preparation of GMP related documents, such as SOPs, work instruction so as to meet respective guidelines enlisted for CGMP.

- Ensure and assist in record generation and record keeping.

- Formulate contamination prevention guideline and organize SOP /Work instructions and record keeping ensuring the same.

- Assist in validation and record keeping wherever essential as per directives for CGMP.

- Assist in identifying and preparing preventive maintenance for critical equipment, as defined under respective guideline for contamination prevention.

- Assist with talent recruitment and lead a highly motivated, efficient and effective team.

- Responsible for training and mentoring associates on the GMP quality team. Assist with CGMP training.

- Works with the department head of quality to assure alignment and compliance with Quality management System laid down, support assessment and compliance and define measures to determine performance objective. Works in close coordination with technical operations, operational excellence and industrial laboratory to identify, evaluate and recommend solutions to challenges identified during CGMP audit and from measures of performance objective for ensuring continuous improvement as an integral part of plant operation.

Manages change through change management process and monitors change control document as a part of change approval process..

- Plans and participates for CGMP audits of manufacturing activities to ensure compliance with all pertinent regulations and company generated SOPs.

- Prepare clear and concise written reports of audit observation, including assessment of compliance, assesses adequacy of action plan. Provide recommendation for corrective action and track corrective action commitments until closure

- Performs batch release activities for product manufactured from CGMP plant.

- Manages product complaints for commercial product and ensures appropriate investigations are conducted and CAPAs taken, feedback provided and tracks investigation to ensure closure of complaints.

- Manages Quality Assurance third parties contracted to perform any function in support of CGMP manufacture of commercial product from the GMP plant.

- Monitor team productivity, identify issues, root cause and develop required resolution plans.

- Undertake ongoing performance review, feedback and development of team members.

- Co-ordinates for all aspects of process engineering and project requirements with industrialization group, safety and project group.

- Participates in industrialization lab trails to understand the process adopted at lab scale and derives pilot requirement for scaling up the process for pilot. Prepare SOP and WI for pilot plant in line with national and international guide

WHO YOU ARE:

- Masters degree in a scientific or health-related field preferred (Organic Chemistry/ M Pharm)

- 10+ years of relevant experience in GMP Pharma Production Management is required.

- Should have worked in Gujarat in the current or past organisation.

- Prior team handling experience is required.

This individual supervises associates on the GMP Quality team.

- Advanced understanding of the application of CGMPs to early development and commercial products, FDA regulations and ICH guidelines required.

- Must be Proficient in MS Office Suite

Women-friendly workplace:

Maternity and Paternity Benefits

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