The Catania, Italy site is searching for an enthusiastic and experienced individual with a quality mindset for the role of Qualified Person.
Specify the Pfizer Global Supply Sterile Business Operations and the Catania, Italy site.
Why Patients Need You
- Catania PGS manufactures life-saving sterile products for the treatment of infective diseases and oncological conditions.
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The selected candidate will be responsible for the quality release of aseptic drug product.
Key Experience Offer of this Role.
- Leadership authority: Final release authority for drug product. Member of the Site Quality Operations Leadership Team.
- External Ambassador: The Qualified Person will provide guidance to cross-functional teams on the site and will interface with regulatory inspectors about quality and compliance topics.
Primary Responsibilities
- The "Qualified Person" (QP) is legally responsible for the final release of the Drug Product to the market.
- Assure and certify that each batch of medicinal products is manufactured, controlled, fully tested and dispositioned in accordance with cGMP and with the Marketing Authorization requirements in Italy and according to the registered specifications in other markets.
- Inform the Italian Ministry of Health (AIFA) and support the other involved MoH as per Pfizer procedure for notification to management for any issues that could impact product quality for marketed products.
- Actively participate on audits performed by the Italian MoH (AIFA) or any other MoH and carry out the activities required by the Health Authorities.
- The holder of the position is required to have interdisciplinary knowledge and skills, integrated and/or diversified management expertise, decision-making autonomy in the context of company policies with general objectives assigned, management of priorities and responsibility for the results achieved, responsibilities relevant to the company that involve integrated decision making with multiple functional areas and management of corporate resources.
What You Offer
Basic Qualifications
- Degree in Chemistry, Industrial Chemistry or Chemistry Pharmaceutical Technologies or Biology/Microbiology.
- Authorization to practice the profession by sustaining and passing the Professional Qualification Examination.
- AIFA (Italian MoH) Decree authorizing the function as "Qualified Person".
- At least 5 years of experience in the pharmaceutical industry specifically sterile manufacturing facility.
Preferred Qualifications
- Knowledge of national and international regulations relevant to the production and control of pharmaceutical products.
- Deep knowledge of issues related to chemical-pharmaceutical productions.
- Critical thinking.
- Good knowledge of English.
- Adherence to Pfizer Values: Courage, Excellence, Equity and Joy.
Contract Type: Regular
Location: On premise
Relocation Package Available: No
Please send resume in English.
#LI-PFE
#LI-PFE
Deadline to apply: July 6, 2023
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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