QA Process & Cleaning Validation Specialist

QA Process & Cleaning Validation Specialist

Thermo Fisher Scientific | Monza | jobseeker.surfingwave.app | 27/11/24

Work Schedule:
Standard (Mon-Fri)
Environmental Conditions:
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description:
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 a 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 concerning 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, and 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 troubleshooting and finding new solutions to problems.

Main Activities:

• Work in close contact with Clients’ quality teams to develop a robust validation strategy in accordance with Client’s expectations and requirements;
• Review Process and Cleaning Validation protocols and reports for clinical, registration and validation batches manufacturing, in accordance with GMP and corporate standards;
• Provide Qualitative and Technical recommendations to permit plant operation within regulatory requirements (FDA, EMEA, AIFA, etc.);
• Support in drawing manufacturing instructions (MBR) or cleaning procedures (SOP) which need to be validated;
• Support in quality evaluation of process design features and filter validation aspects;
• 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);
• Strong technical attitude and problem-solving skills applying scientific thinking;
• Curious mentality;
• Good interpersonal skills and ability to work in multi-disciplinary teams.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our incredible mission—enabling our customers to make the world healthier, cleaner, and safer.

Apply today! http://jobs.thermofisher.com