Production Quality Operations Officer

Μαρούσι, Αττικής
Μόνιμη
Πλήρης Απασχόληση

Πριν 6 ώρες
Κάντε αίτηση εύκολα

Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.Pharmathen’s highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company’s enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to the company's vision of making a difference in people’s lives.Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Product Quality Operations Officer for the Product Life Cycle Quality team in our Marousi premises.As a Product Quality Operations Officer you will assure compliance with the GMP standards and ISO requirements by supporting the processes of codification system, CoA & CoC, nitrosamines, elemental impurities, statements, annual product quality review and participating in relevant activities related to Product Quality Operations.More particularly:What you will do:

Support data entry and maintenance of product quality operations information within the SAP Product Profile application
Prepare and update risk assessment reports related to Nitrosamines, Elemental Impurities, and Residual Solvents in accordance with current guidelines
Participate in the preparation of risk assessments for product quality operations-related matters
Contribute to product quality operations investigations (e.g., deviations, customer complaints), in collaboration with relevant internal and external stakeholders
Assist in the initiation and evaluation of Change Plans (related to APIs, variations), and support required actions related to the revision of product profiles, serialization, nitrosamines, statements, elemental impurities, SAP codes, product launches, etc.
Participate in meetings with internal and external stakeholders concerning product quality operations issues, including serialization, declarations, elemental impurities, nitrosamines, product quality reviews, SAP codes and related ones
Contribute to the preparation of Annual Product Quality Review (PQR) reports
Handle the description change of SAP codes
Prepare templates for Certificates of Analysis and Certificates of Conformance for finished products
Handle the customer requests for Product Quality Reviews (PQRs), nitrosamines and elemental impurity risk assessment reports and product statements (e.g., gluten-free, halal, alcohol-free)
Contribute to the preparation of procedures and technical directives for the handling of the serialization, product quality review, nitrosamines & elemental impurities, SAP codes etc.
Participate in uploading the certificate templates into the LIMS system

RequirementsThe ideal candidate should have:

BSc Degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or another relevant sector
Desirable 1-3 years’ experience in Quality Management / Quality Assurance or relative role in a Pharmaceutical Industry

Job-Specific Skills:

Excellent communication in English language (writing & speaking)
Computer literacy
SAP knowledge
Ability to prioritize tasks and meet deadlines
Exceptional communication skills

BenefitsWhat you'll gain:

Involvement in a high-caliber, team-oriented and dynamic atmosphere
Exposure to challenging business issues and practices
Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.

Pharmathen