Operations Head

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.