Operations Coordinator

The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Train or ensure training of staff on procedures (as the Job Qualified Trainer). Operate production lines when permanent operators are absent. Review production packaging records before Quality Assurance review. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Languages: English Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; Capable of leading continuous improvement projects with support departments. Ability to manage projects. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability Employees holding this position will be required to perform any other job-related duties as requested by Management.

Created: 2025-09-28