Section Manager- Production shall be responsible for overseeing and managing the production of vaccines within a designated section of Vaccine Drug Product Plant,Baddi and shall ensure that production processes are carried out efficiently, safely, and in compliance with all regulatory requirements.
RESPONSIBILITIES:
- Develop and implement production schedules to meet demand while optimizing resource utilization and minimizing downtime.
- Ensure the execution of validation activity of Formulation, filling & material preparation area/ equipment's dedicated for production Line with co-ordination with QA or internal and external agencies as per validation due schedule.
- Review of SOP's, validation protocols, extended documents/reports preventive maintenance schedule, log books, calibration schedules and regulatory guidelines.
- Ensure the cleaning, Operation, documentation & maintenance of all dispensing, formulation, filling, solution & material preparation area as per planning of production Line .
- Ensure GMP compliance as per the applicable National and International rules and guidelines Such as Schedule M and World Health Organization (WHO).
- Manage and evaluate entire production process.
- Contribute to production planning and budgeting.
- Lead and monitor quality assessments to ensure customer satisfaction
- Maintain a safe production environment.
- Coordinate with key internal and external production stakeholders.
- Lead and motivate a team of production staff to achieve production goals and maintain a positive work environment.
- Identify opportunities for process improvement and implement initiatives to enhance efficiency, reduce costs, and improve product quality.
- Prepare and or review the assessments associated to the Software or GXP equipments.
- Prepare and or review the DIM associated to the Software or GXP equipments.
SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES
- Effective communication skills to interact with various stakeholders, including team members, management, and regulatory authorities.
- Must have experience to handle the QMS element i.e. deviation, change control, CAPA, incident etc.
- Must be proficient in preparation of documents such as SOP, Gap assessment, risk assessment
