Bayer HealthCare Manufacturing is looking for a bright candidate as Qualification Specialist for the Garbagnate plant.
You will be part of a qualification and calibration group in the Engineering area and will be requested to interface and co-operate with different people from other site departments: Production, Quality Control, Quality Assurance, HSE.
The major tasks are:
- Preparation of qualification and periodic re-qualification protocols for GMP relevant equipments, systems and utilities such as HVAC, Purified water, etc.
- Execution of qualification tests on production equipment, control systems and utilities in accordance with the quality standards compliant with GMP regulations.
- Review and archiving of qualification protocols from suppliers and verification of executed qualification protocols, internally and by the external specialized consultant company
- Preparation of procedures relevant to qualification and calibration activities in accordance with the global procedures and compliant with GMP regulations
- Management of calibration scheduling as well as review and record of relevant calibration certificates
- Degree in CTF or Engineering or similar
- Previous 2 years of experience in the same role in a pharma company or in the field of quality assurance/qualification in the GMP environment
- Good knowledge of GMP requirements and experienced as support in GMP-based inspections
- Required good interpersonal skills, smart, having good cooperation and communication skills
- Able to read electric and pneumatic schema as well as process schema
- In-depth knowledge of the Office package
- Nice to have good Knowledge of the most common process instruments (pressure and temperature probes, manometers), of measuring principles and uncertainty of measurement and of calibration module in SAP environment
- Fluency in English (written and spoken) and in Italian
Type of contract: permanent
Per candidarti vai a www.linkedin.com.
