Final Products Reviewer (Sapes)

We are one of the leading complex drug delivery and formulation developers, using our key in-house technologies to support improved patient compliance. We service a broad partner network of over 250 customers in over 90 countries throughout Europe, North America, South America, Middle East, Asia, Australia and Southern Africa.

Our portfolio consists of over 100 products, and today we are working on one of the most extensive and advanced pipelines in Long Acting Injectables, Sustained Release formulations and Preservative Free Ophthalmics, produced in our in-house US-FDA and EU-approved facilities.

We proudly employ more than 1,200 people from over 22 different nationalities across 9 locations. We welcome the opportunity to expand our collaboration with existing partners as well as to establish new partnerships, while remaining committed to our vision “to make a difference in people’s lives” through our everyday activities and our products.

Due to continuous growth and expansion, Pharmathen offers a great opportunity for career development and is seeking to recruit a Final Products Reviewer to join our Quality Control LAI team at our Sapes, Rodopi premises.

As a Final Products Reviewer, the ideal candidate will review documents related to Quality Control Laboratory of LAI unit.

More particularly:

What you’ll do:

• Review Batch records of raw materials, excipients, packaging materials, stability studies documentation and finished products for proper compliance with established specifications.
• Create, maintain, and update COA/COC and Specifications.
• Support in activities as Change Control, and ERP system functions
• Maintain Quality Systems covering document control, specifications, SOP’s, and regulatory documents.
• Support in miscellaneous activities as deemed necessary by the QC management team.
• Liaise with Quality Assurance and Production department for information exchange so as to support in release procedures.

Requirements

The ideal candidate should have:

• Minimum BSc Degree in Chemistry or relevant field
• At least 2 years of professional experience in a similar role
• Experience in a GMP or GLP environment will be considered an asset
• Excellent communication in English language (writing & speaking)
• Knowledge of MS Office
• Good Technical Writing ability

Job-Specific Skills:

• Excellent communication in English language (writing & speaking)
• Knowledge of MS Office
• Good Technical Writing ability

Benefits

What you'll gain:

• Involvement in a high-caliber, team-oriented 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.