Manager, QA
4 mesi fa
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Monza site is looking for a Quality Assurance Manager and Qualified person to lead a QA Operations team and bring valuable contributions both as individual professional and people leader.
MAIN SCOPE OF THE POSITION/ RESPONSIBILITIES:
As QA Manager and QP you will coordinate a team of Quality Operations professionals and wield authority inside the Plant in regards of what foreseen by law (D. Lgs 219/06 and later supplements) towards Authorities, in particular towards the Italian and European Public Health Authorities and being the liaison between Authorities and the plant.
You will be responsible, as foreseen by DPR 309/90 and later supplements, of management of the controlled drugs, only if authorized by Ministero della Salute.
ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES:
- Acting as liaison between the Plant and the National Public Health Authorities (AIFA, UCS), National Public Safety Authority (Police, National Exercise and tax crimes authority, ASL) in regard of drugs and controlled drugs.
- Assure that each batch of drug is produced and controlled in compliance with current laws and with conditions defined in the product marketing authorization.
Assure that each batch of drug coming from a country not belonging to the European Union is properly analyzed, that a quantitative analysis of all active principles is made and that any other test necessary to assure the quality of products is made, in compliance with what indicated in the product marketing athorization, reserved the right of what defined by mutual agreements.
Certify and attest on specific documentation that each batch is produced in compliance with the provisions indicated in the product marketing authorization.
Release the finished products for the market (Batch Release).
- Authorize the unpacked products release for the delivery to clients.
Guarantee that all documentation required by law and by GMP is properly compiled and filed for the right period of time.
- Communicate immediately to AIFA and to the Company any substantial irregularity in the products already launched in the market.
- Collaborate actively in occasion of each inspection by Health Autorithies and guarantee that any action requested by the Authorities during the inspection is made. Certify that the pharmacologically active substances used within the plant have been produced in compliance with GMP
The QP, in order to carry out his role, avails himself of the staff settled in the legislative decree 219/06 and in the GMP (personnel) and assures, thanks to this structure, the
**Requirements**:
- MsC in CTF, Pharmacy, Biology or similar
- Deep understanding of GMP regulations and sterile injectable drugs manufacturing and batch release process
- Knowledge of regulatory matters and dossier
- At least 10 years of experience in a Sterile Injectables manufacturing faciltuy and at least 6 years of experience in the QA function
- Experience in a multinational/international environment is preferred
- Fluent English and Italian
- Proven People Leadership skills
- Active listener, with good communication and negotiation skills
- Problem solver, focused on data-informed decision making and risk analysis.
- Goal and client oriented
- Eligible to act as a QP in Italy
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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