Urgent Opening for General Plant Manager for Pharmaceutical -

Position– GM Plant (General Plant Manager)
Job Location– Bhiwadi, Rajasthan
Experience- 12-20 Years. Must have experience in a sterile injectable manufacturing company

CTC– 15 to 20 Lacs

Job Purpose for General Plant Manager:

This role will oversee all aspects of sterile API and injections manufacturing but not limited to: all employees and processes related to the production and manufacturing of all products/medicines produced, quality assurance/quality control, quality compliance, inventory & materials management. The Vice President will work closely with the Managing Director and lead the site team to acquire EU GMP certification.

Job Responsibilities for General Plant Manager:

General:
Interfaces with the EU project teams to provide overall expertise for Production,
QA/QC, Engineering, and Compliance topics relating to facility, utility, and equipment design, qualification, and validation, etc. for Sterile API and injectable products.
Ensures that activities related to project implementation meet cGMP requirements, performing self-inspection as required to ensure compliance of operations during project execution and routine manufacturing activities.
Provides Quality review and oversight at engineering project concept, design verification, commissioning and qualification activities including assisting in the compliant resolution of issues.
Provides EU cGMP training to QA, QC, Production, Engineering & other departments and ensures guidelines are implemented throughout the organization, as applicable.
Commits to plant safety procedures. Production and Manufacturing Oversight:
Oversee and ensure that every product unit is of high quality and exceeds all the Company’s current Good Manufacturing Practices (cGMP).
Plan, organize, direct and run optimum day-to-day operations to exceed our customer’s expectation
Ensure sterile production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures are accurate and personnel training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility.
Oversee investigations and CAPA actions for non-conformances for Bulk and Sterilized products.
Oversee and ensure that SOPs are maintained and other manufacturing specifications and oversee the department budgets.
Continuously improve workflow and ensure that it is line with the budget, including controlling overtime expenses.

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Quality Assurance/ Quality Control:
In collaboration with the Quality team, provide direction for complex deviations and complaint investigations; manage media deviations, CAPAs, and Complaint handling and ensure that complaints are escalated, investigated and resolved in a timely manner.
Coordinate activities to support follow-up on complaint trend investigations for medical (adverse events).
In collaboration with Quality, develop and approve cGMP documents including for manufacturing and production area, but not limited to, SOPs, batch records and specifications, ensuring optimal efficiency.
Primary driver for the quality control and compliance aspects of product transfers and organization optimization.
Lead or support regulatory or internal audits in partnership with QA. Provides support for quality audits, initial site approvals, and due diligence activities.
Develops audit plans, due diligence plans, implements readiness plans, reviews audit observations and responses, and maintain a corrective action plan timetable.
Contributes to decisions on product quality, compliance, and regulatory conformance issues for sterile, injectable products.
Inventory, Supply Chain & Materials Management:
Oversee and ultimately be responsible for production scheduling in avoidance of stock-outs and spoilage.

The persons who are interested in General Plant Manager please share your resume at [email protected]

Note: Don’t forget to mention Pharma Awareness as a reference.

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