Job Description

- Partner with business leadership to understand the business requirement and try to fulfil or suggest improvement plan.

- Responsible for meeting production schedules with efficient and optimized use of resources and machine time.

- Managing multiple priorities in a fast paced manufacturing environment.

- Budget preparation and adherence with approved budget.

- Interfaces with supply chain to develop mid-and long range master production schedules.

- Plan, organize, and control the production process to ensure the efficient and timely manufacturing of products.

- Monitor production schedules and adjust as necessary to meet demand and maintain inventory levels.

- Ensure adherence to standard operating procedures (SOPs), batch records, and regulatory guidelines.

- Ensure that all products are manufactured in compliance with Good Manufacturing Practices (GMP), FDA and other relevant regulatory standards.

- Collaborate with the Quality Assurance (QA) department to ensure that quality checks and audits are performed regularly.

- Implement corrective and preventive actions (CAPA) to address quality issues.

- Responsible for review of QMS documents, qualification protocols and other online documents for any implementation of CAPA.

- Responsible to conduct internal audit/self-inspection to ensure compliance to cGMP and other regulatory requirements.

- Identify and implement process improvements to enhance efficiency, reduce waste, and optimize the use of resources.

- Collaborate with the Research and Development (R & D) team to scale up new products from pilot to full-scale production.

- Develop and manage the production budget, ensuring cost-effective use of materials, labor, and equipment.

- Ensure that all production activities comply with local and international regulatory requirements.

- Prepare and maintain necessary documentation for audits and inspections by regulatory authorities

- Oversee the maintenance and calibration of production equipment to ensure optimal performance and minimal downtime.

- Stay updated with the latest technological advancements in pharmaceutical manufacturing and evaluate their potential application.

- Responsible for monitoring the scheduled and unscheduled validation activities and ensure its completed as per approved protocol. Ensure the implementation of changes.

- Review and approval of the Apex document such as Quality Policy, Validation Master Plan, Site Master File, Quality Manual, Quality Agreements, Annual Validation planner for Equipment, utility, process etc.

- Review and approval of Validation related documents and miscellaneous protocols and reports.

- Review and approval of Validation/Qualification protocol and reports related to Computer System Validation.

- Prepare and submit regular reports on production performance, including key performance indicators (KPIs), to senior management.

- Maintain accurate records of production activities, equipment maintenance, and staff training.

- Lead, mentor, and develop a high-performing production team, fostering a culture of continuous improvement and accountability.

- Conduct regular performance reviews, identify training needs, and facilitate skill development programs for the production team.

Preferred candidate profile

- Bachelors degree in Pharmacy. A Masters degree or MBA is a plus.

- Minimum of 5 years + of experience in pharmaceutical manufacturing, with at least 5 years in a leadership role.

- In-depth knowledge of injectable manufacturing processes, GMP, regulatory requirements, and quality systems.

- Strong leadership, communication, and problem-solving skills.

- Proficient in using production management software and familiar with lean manufacturing principles.

- Familiarity with ERP systems (e.g., SAP) used in pharmaceutical manufacturing.

- Good leadership skills.