DescriptionA leading pharmaceutical company.
Responsibilities
- Manage and continuously improve the qualification and validation system, ensuring the development and implementation of relevant procedures.
- Ensure timely completion of qualification and validation activities for equipment, production facilities, and utility systems, including re-qualification and re-validation when required.
- Prepare, review, and approve qualification and validation protocols and reports in compliance with GMP requirements.
- Review and assess qualification/validation documentation prepared by external vendors prior to acceptance, ensuring compliance with company requirements.
- Issue deviation reports during qualification/validation activities and investigate issues in collaboration with the technical team to ensure timely resolution.
- Validate spreadsheets used by the department and perform periodic reviews of technical logbooks.
- Oversee the proper implementation of the preventive maintenance program.
- Monitor and coordinate corrective and preventive actions (CAPAs) within defined timelines.
- Manage technical department purchase orders.
- Maintain, update, and organize mechanical and electrical drawings of facilities and production systems in accordance with engineering best practices and GMP requirements.
- Conduct Engineering and EHS Risk Assessments for equipment and utility systems to ensure safe operation and product quality.
- Prepare and document Engineering and EHS Risk Assessment reports.
- Deliver EHS training sessions to involved personnel when required.
- Conduct internal EHS audits and inspections.
- Prepare periodic management reviews of EHS system performance.
- Manage, organize, and ensure timely execution of the company compliance calendar related to external authorities and regulatory bodies.
- Ensure EHS procedures are developed, implemented, and maintained in compliance with ISO 14001 and ISO 45001 requirements.
- Work closely with managers and employees across departments to support engineering and EHS activities.
- Provide technical and EHS support to management as required.
Requirements- BSc in Mechanical Engineering (University / Technological Institute) or other relevant engineering discipline.
- Minimum 2 years of experience in industrial production or maintenance, preferably in the pharmaceutical or food industry.
- Previous experience in developing and maintaining procedures, protocols, reports, and technical documentation.
Benefits- Competitive salary
- Continuous training and professional development in a regulated industrial environment under GMP standards
