Quality Assurance Oversight Senior Officer

Παλλήνη, Αττικής
Μόνιμη
Πλήρης Απασχόληση

Πριν 16 ημέρες
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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 QA Oversight Senior Officer for the Quality team in our Pallini premises.As a QA Oversight Senior Officer, you will be responsible for overseeing and ensuring the quality of operations within the organization, through documentation related activities, and manufacturing, packaging and QC activities oversight.More particularly:What you will do:

Collaborate with cross-functional teams to ensure that all products and processes comply with quality standards
Takes part in preparation, authorship/review and issuance of the Site SOPs and TDRs as well as other controlled documents of the Quality System of the company.
Ensure that all operations are conducted in compliance with company policies, industry standards, and regulatory requirements
Identify areas for improvement within operational processes and contribute to finding solutions to enhance efficiency and quality
Support site trainings on quality-critical operations
Conduct regular on spot inspections of operations to ensure adherence to quality standards and identify potential issues
Work closely with QC, production, supply chain, and other departments to ensure a unified approach to quality across all operations
Collaborate on preparation of Deviations, Change Management, complaints and all site’s operations oversight, KPIs, utilities/environmental monitoring, Aseptic process Simulations and various transfer and engineering projects
Active participation in SOPs preparation/review, Document Management, Training system, Audit management including Self Inspection, Risk Management, Escalation process, Complaint management, CAPAS, as well as other Quality Management System policies such as OOS/OOT investigations, various statistical evaluations, APQR, Process Validations, Cleaning Validations, stability oversight as well as CSV projects and Data Integrity Campaign
Support customer audits and inspections, as well as audit and inspection response actions related to shop floor findings and implement sustainable fixes
Work with production teams to improve process robustness and reduce recurring quality issues
Collaborate with cross-functional teams to ensure that all products and processes comply with quality standards
Monitor production operations in shop floor

RequirementsThe ideal candidate should have:

Bachelor’s degree in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
At least 3 years of experience in pharmaceutical manufacturing or Quality Assurance – previous experience in sterile products is desired

Job-Specific Skills:

Excellent communication skills and ability to enforce quality requirements on the shop floor
Strong knowledge of EU GMP, Annex 1 (sterile products), and quality risk management (QRM)
Hands-on experience with sterility assurance programs, aseptic processing, and cleanroom monitoring
Ability to work in a fast-paced, production-driven environment with strong problem-solving skills
Strong initiative skills
Good communication in English language (writing & speaking)

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