We’re Hiring: Operations Head at Gufic Biosciences Limited
Operations Head
Job description
The Operations Head will oversee and manage all aspects of the production process for injectables in a pharmaceutical manufacturing facility. This role is critical in ensuring that production targets are met efficiently while maintaining the highest standards of quality, safety, and compliance with regulatory requirements. The Operations Head will lead a team to optimize manufacturing processes, control costs, and drive continuous improvement.
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 15 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.
Willing to Relocate in Indore, M.P.
Experience required: 15 – 20 Years
Location: Pithampur (M.P.)
Interested candidates with work experience in injectable formulations can mail resume on hr.indore@guficbio.com.
