Quality Control Laboratory Supervisor

7 mesi fa

Aprilia, Italia Recordati Group A tempo pieno

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life

**Job purpose**:
The Quality Control Lab Supervisor is responsible to supervise and direct the day-to-day activities of the laboratory division, in accordance with cGMP. Reports to the Quality Control Laboratory Manager and collaborates with him to ensure that day-to-day work and testing priorities are met to support production and customer demands.

**Key responsibilities**:

- Direct/Coordinate the quality lab activities to plan and establish work schedules, and assignments in support of production and organizational goals.
- Support laboratory staff; access to training, manage performance and development of staff.
- Reports on performance, and metrics for each analyst to QC Manager.
- Ensures that all testing is performed in a timely manner and with accuracy to support the release of the product.
- Initiates and Performs laboratory investigation when necessary.
- Ensures raw material testing for approval and supply chain management is performed, documented, and communicated to the appropriate departments as needed.
- Ensures Intermediates and API testing, batch release and stability.
- Assists with new product development and timelines: analytical methods development, analytical methods validation, verification and transfer.
- Develop, maintain and communicate all applicable SOP's (Standard Operating Procedures).
- Ability to write/execute protocols, and write reports for method validations.
- Reviews and approves laboratory notebooks.
- Reviews all quality documentation related to Methods, Specifications, Protocols, Reports.
- Ensures all equipment is maintained in a calibration status and properly working according to cGMP standards. Collaborates with the QC Manager for the selection, purchase and installation of new equipment.
- Maintains proper record keeping, calibration, and repair of analytical instruments to ensure compliance with GLP and GMP.
- Perform the qualifications and validations of test methods, and instruments.
- Troubleshoots and maintains instrumentation.
- Maintains inventory and ordering of laboratory supplies.
- Maintain all housekeeping, regulatory and GMP requirements.
- Maintains inventory and ordering of laboratory supplies.
- Other duties may be assigned as deemed appropriate by management.

**Required skills, qualifications, experience and behaviours**:

- Bachelor's degree, preferably in Chemistry, Biochemistry or Pharmaceutical Chemistry.
- Knowledgeable of cGMP, EMA, FDA and ICH guidelines.
- 5+ years of experience in quality control laboratory, preferably in pharmaceutical companies.
- Working Knowledge of scientific principles for wide range of analytical techniques is required.
- Strong interpersonal and communications skills, written and oral.
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
- Ability to drive functional, technical and operational excellence.
- Good problem-solving skills and logical approach to solving scientific problems.
- Solid understanding of EMPOWER is strongly preferred.
- Routine use of MS Excel, MS PowerPoint, MS Access, and MS Word.
- Good English speaking and comprehension.
- Available to adapt to flexible working hours.

At Recordati we believe in people Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

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