AM/DM/Manager - Aseptic Manufacturing Assurance - Pharma

We have an opening at Visakhatnam for a leading Pharmaceutical MNC is lookinf for Asst. Manager / Dy. Manager / Manager / Sr. Manager - Manufacturing Assurance & Batch Release

Support the Head of Quality Operations in the manufacturing quality and disposition decisions. Ensure sustainable quality oversight is implemented across manufacturing operations in the aseptic processing areas.

- Hire, develop, train and mentor the manufacturing quality assurance team to support the manufacturing operations by providing quality oversight.

- Accountable for day to day manufacturing quality decisions in the manufacturing floor.

- Ensure a robust system is developed and maintained for managing investigations, change control and batch disposition.

- Support the manufacturing quality assurance team in defending the processes and decisions in regulatory inspections and internal assessments.

- Play a key role in manufacturing trouble shooting and provide recommendations to aid the quality operations head in making disposition decisions.

- Develop and implement manufacturing quality assurance training and qualification program

- Conduit between corporate functional teams and site quality team in global manufacturing quality assurance initiatives pertaining to aseptic processing.

- Ensure robust aseptic processing and clean room on the job training program is in place and maintained for all personnel working in aseptic areas.

- Support the site quality unit in development and management of metrics for the aseptic manufacturing quality area.

- Oversight in designing /preparedness of manufacturing of exhibits batch /submission /launch of commercial batches.

- Support the implementation of training activities and GMP Training curricula

- Drive continuous improvement initiatives for aseptic manufacturing areas based on key performance indicator data.

- Partner with Company sister sites in bench marking manufacturing quality practices for the Vizag site.

- Review trends from internal assessments and external inspections to assess the state and control of manufacturing quality system and practices in the aseptic manufacturing areas and drive continuous improvements.

- Represent company Vizag site in company communities of practice in aseptic processing.

- Determine continuous training improvements for aseptic manufacturing and engage Company sterility assurance experts to impart training at the site.

Note: injectable experience is must

Aruna
Formula HR Consulting