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Qualified Person Catania Site


Ayer, MA 01432
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Job Details


The role is officially acknowledged as "Qualified Person" and is legally responsible for products released to the markets where the role of the "Qualified Person" is recognized.

The role has the obligation to fulfill all requirements of Decree N219/2006 and related updates.

**Main Responsibilities**

+ Assure that each batch of medicinal products is manufactured and controlled in accordance with cGMP and with the Marketing Authorization requirements.

+ Verify that, medicinal products coming from countries outside of the EU, that each imported batch undergoes full qualitative testing and quantitative testing on at least all active ingredients and any other analysis that is deemed necessary to guarantee the quality of medicinal products in accordance with the Marketing Authorization requirements, unless otherwise established through mutual recognition agreements.

+ Certify that each batch of medicinal products, manufactured at the Site or imported outside of the EU has been tested and controlled in accordance with cGMP and Marketing Authorization requirements and be responsible for the filing of related documentation.

+ Determine the disposition of each batch of the medicinal products manufactured at the Site in accordance with the Marketing Authorization requirements in Italy and 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) in accordance with legislative decree N 219/2006 or any other MoH and carry out the activities required by the Health Authorities.

+ Assure that hygienic conditions in the production areas are maintained in accordance with cGMP.

+ Support the Quality Operations Leader/Director for Quality issues that can impact product quality relevant to the Site Manufacturing Plant in conformance to the requirements of current laws, corporate policies and conformance standards, Catania Site Quality Review Team, Area Quality Review Team and Corporate Global Quality requests.

+ Substitute, when required, the Quality Leader/Director for delegated activities.

+ Supports the individual and collective short term and long-range objectives to achieve improved effectiveness efficiencies and to assure fail-safe Quality and Compliance.

+ Supports with continuous improvement activites for systems and procedures

+ Provide support in exeution of Quality and site objectives.

+ Evaluate and approve several type of documents such as the Annual Product Review/Product Quality Review (APR/PQR) for medicinal product manufactured at the Site for whose release is responsible, Expedite Complaint reports and trends , ontractors deviations, Stability/Environmental Monitoring trends among other documents

+ Review and approve QAR as additional approver for significant deviations as established in site procedure.

+ Regulatory Declaration signature (if required)

+ Evaluate and approve ELR (Evaluation labeling & repackaging ) if required

+ Evaluate and approve QC Monographs & Methods, if required

+ Support effective management of Quality Operations Budget


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".

Experience in Pharmaceuticals Production Operations, Quality Control or Quality Assurance & Compliance. Experience in aseptic processes is desirable

Good understanding of English language including writing, reading and oral communication.

Knowledge of National and International regulations relevant to the production and control of pharmaceutical products including US FDA.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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