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
Job Title
SECTION MANAGER-PRODUCTION