Operations Head

Job Description

Role & responsibilities:

- 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 20 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.