Biocon - Senior Role - Injectables/Fill Finish Manufacturing

- Candidate must have 16 to 24 Years of Core Fill finish Manufacturing Experience

- Develop the manufacturing team and supervise manufacturing activities as per the plans.

- Coordinate with the packing team for packing of products day to day basis based on planning.

- Should have sound knowledge of the regulatory requirements like USFDA, MHRA, ANVISA and MCC etc.

- Should have a sound knowledge related manufacturing and packing operations of the sterile products

- Create awareness about Standard Operating Procedures, product specifications and safety requirements.

- Plans the production activity for the plant in co-ordination with planning department.

- Review and approve production related documentation (the SOPs, Batch Records etc).

- Identify opportunities for continuous improvement in plant operations and implement them through management team.

- Ensure effective utilization of resources in the plant.

- Provide appropriate & effective resources for achieving production objectives of the plant.

- Training & development of plant personnel.

- Provide regular reports and inputs to Senior Management.

- Own up audits related to the plant in participation with quality.

- Liaise with various support functions for carrying out smooth operations.

- Resolve issues if any & ensure that the regulatory/audit requirements for the plant are met.

- Conduct meeting with the various departments like QA/ QC / Warehouse/ Maintenance / EHS/ HR to solve the trouble shooting operations, to achieve the day to day production targets .

- Hands-on experience in operation of Filling machine, Lyophilizes, Autoclaves, Particle counter,Intigrity apparatus,Filteration techniques, Different type of filters, clean equipment- s, Mobile tanks, Sterilization of equipments,CIP, SIP operation etc

- Should have in-depth knowledge in Current Good Manufacturing Practices. (cGMP)

- Experience in technology transfer & scale-up operations.

- Knowledge of new product development programs.

- Should have good communication skills.

- Resource management skills

- Demonstrated ability to optimize costs.

Desired Profile:

Candidate with 16 - 24 years of experience in Fill Finish manufacturing is preferred.

Education: B Pharm / M Pharm / MSC