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.

Bihar

Kolkata

Operations Head - Pharmaceutical Manufacturing 

Job Description for Operations Head - Pharmaceutical Manufacturing  in Essex Company in  Bihar Kolkata Goa for (5-14) years of experience. Apply Now!