**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Thermo Fisher Monza site is a world class contract manufacturing and development facility, specialized in aseptic injectable drugs, with a growing focus on biologics and vaccines.
Location/Division Specific Information
Monza (MB), Italy
As Quality Assurance P&CV Specialist, you will become part of a proactive and dynamic team, which maintains an high quality standard on P&CV of new products manufacturing in Monza site.
What will you do?
You will join QA Process & Cleaning Validation Team, part of the Quality Unit.
In this role you will lead client's projects from a quality and validation standpoint for what concerns the manufacturing P&CV activities, assisting MS&T and Technology Transfer Project Managers on customer technical transfers, modifications to existing processes or adding new processes that will improve process safety, reduce plant operating costs as well as improve product quality and efficacy. Ultimately your quality support will be essential in manufacturing new life-saving sterile drugs.
A dedicated attitude will be key in meeting Regulatory expectations and in exceeding client's expectations. A strong technical mentality and the ability to "think creatively" will be fundamental in setting the troubleshooting that allows you to find new solutions to problems.
The main activities you will be involved in are:
- To work in close contact with Clients' quality teams to develop a robust validation strategy in accordance with Client's expectations and requirements;
- To review Process and Cleaning Validation protocols and reports for clinical, registration and validation batches manufacturing, in accordance with GMP and corporate standards;
- To provide Qualitative and Technical recommendations to permit plant operation within regulatory requirements (FDA, EMEA, AIFA, etc.);
- To support in drawing manufacturing instructions (MBR) or cleaning procedures (SOP) which need to be validated;
- To support in quality evaluation of process design features and filter validation aspects;
- To ensure that new product introduction and all process changes are adequately evaluated and managed through change control management;
- Support in preparation and participation to Clients' and Regulatory audits with regards to validation activities.
Graduation
Degree in Pharmacy / CTF / Biological Sciences / Chemistry / Engineering / Biotechnology / Physics.
Experience
At least 1-2 years of experience in pharmaceutical/chemistry industry;
Experience in validation, preferably with liquid and lyophilized sterile injectables drugs will be considered as a plus.
Knowledge, Skills, Abilities
- Italian and English (at least B2) proficient;
- Knowledge of basic sterility assurance concepts;
- Knowledge of basic analytical methods (chemical and microbiological);
- Curious mentality;
- Good interpersonal skills and ability to work in multi-disciplinary teams.
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