Περίληψη
About the Role
Major Accountabilities
- Guarantee the correct operation of the equipment, systems, plants present in the production site through the coordination of all the Technical activities, carried out by internal and external resources
- Coordinate the technical activities on the equipment / systems as improvement projects and upgrade projects on the same ones
- Support the production activities participating in the multi-department workshops and projects
- Guarantee the Aseptic process compliance (by equipment upgrade) and Aseptic Process improvement
- Collaborate with MS&T and Production department to understand better their needs and processes for systems compliance, efficiency, and reliability (evaluating needs for upgrade or substitution)
- Accountability and/or responsibility for the GMP documentation both external and internal
- Improvement of the qualification, validation and other GMP / technical documentation adapting it to the corporate standards
- Execute qualification (and sometimes) validation activities or coordinate external resources in the execution under own accountability
- Support the process of Continuous Improvement and Compliance for aseptic processes
- Support eCompliance improvement projects
- Guarantee the safety of internal and external resources working on the equipment, in accordance with applicable normative and corporate procedures (through the implementation of preventive measures).
- Participate in the technical investigations on the GMP deviations on the site production systems and processes
Key Performance Indicators
Active collaboration in multi-department teams to guarantee:
- Compliance of the production processes (by equipment and systems compliance)
- Execution of the Production planning (by efficiency and reliability of the equipment)
- GMP compliance and eCompliance of the equipment and systems (by respecting maintenance, calibration, and requalification plans)
- HSE performance indicators (safety as principal)
- Qualification and Validation of the new equipment or systems respecting scheduling and budget of the Investment projects
- Requalification and Revalidation of the existing equipment / systems up to Validation Activity Schedule (yearly qualification / validation plan) – on time
- Execution of the Site Quality Plan
Job Dimensions
Subordinate Functions: None
Number of Associates: Direct: 0; Indirect: 2-3
Financial responsibility (where appropriate): N/A
Impact on the organisation (where appropriate): High.
Efficiency and Reliability of the equipment as well
as GMP Compliance and eCompliance is
necessary pre-requirement to guarantee:
- Product quality
- Production planning
- Quality Plan respect
Ideal Background (State the minimum and desirable education and experience level)
Education: Batchelor Degree In Engineering (5 years) – preferably electrical or mechanical
Languages: Fluent English spoken and written. Basic Knowledge of the Pharmaceutical and Technical terminology in English
Skills (and Experiences) desired:
- 5-year Direct experience in Pharmaceutical companies or Consultant Companies for Pharmaceutical industry
- Direct experience in managing pharmaceutical equipment (maintenance, calibration, requalification) with particular attention to Aseptic processes (sterilisation, depyrogenation, freeze drying, aseptic filling, WFI loops, …)
- Direct experience and knowledge of GMP documentation (Risk Assesment, Change Request/Management, Root cause analysis, Statistical analysis of production and performance indicators)
- Direct experience in preparation of the GMP documentation for pharmaceutical equipment
- Direct Experience in handling the projects for upgrade or substitution of the existing pharmaceutical equipment
- Direct experience in management (definition, follow-up) of budget for the equipment investments
- Direct experience in management and coordination of external contractors and consultants
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