Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.
Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.
Pharmathen offers a great opportunity for career development and is seeking to recruit an Product Quality Lifecycle Senior Officer to join our Corporate Quality Management team at our Sapes premises.
The Product Quality Lifecycle Senior Officer is responsible for ensuring that all products meet the company's quality standards and specifications.
More particularly:
What you’ll do:
- Lead and coordinate complaint investigations, including initial assessments, root cause analysis, and documentation
- Ensure timely and thorough investigation of LAI and OSD product complaints
- Collaborate with cross-functional teams (e.g., manufacturing, QC, regulatory affairs) to gather data and resolve issues
- Identify trends and recurring issues from complaint data
- Support internal and external audits related to complaint management
- Provide guidance and coaching to team members involved in investigations
- Communication with customers regarding any quality queries related with the validation activities of the facility
- Take 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
- Participate in multidisciplinary team for performing investigations
- Operate as a trainer in basic training sessions such as GMP training, Gowning SOPs, etc
- Ensure compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and EU cGMPs
- Work closely with production, R&D, and supply chain teams to ensure quality standards are integrated throughout the product development and manufacturing processes
- Ownership and support of activities related with Process Validation, Cleaning Validation, OOS/OOT investigations, various statistical evaluations, various studies, APQR and stability oversight
- Active participation in SOPs and Master Records preparation/review, Complaint management, Risk Management, Escalation process, KPIs monitoring, CAPAS, as well as other Quality Management System policies and site quality operations oversight and Data Integrity Campaign, as well as various transfer and engineering projects
- Participate in customer audits and authorities’ inspections
Requirements
Minimum Qualifications:
- Educational background in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
Minimum Experience:
- Minimum 2 years’ experience in Quality Management
Job-Specific Skills:
- Excellent communication in English language (writing & speaking)
- Ability to prioritize tasks and meet deadlines
- Exceptional communication skills, strong project management skills
- Broad knowledge and extensive experience on pharmaceutical quality systems
- Extensive knowledge of European GMPs to be able to ensure compliance with national and European standards and legislation
- Effective problem solver
- Strong initiative and creativity skills
Benefits
What you will 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/ scientific 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.
Skills Required
- Degree in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
- Minimum 2 years' experience in Quality Management
- Extensive knowledge of European GMPs and EU regulatory standards
- Broad knowledge and extensive experience with pharmaceutical quality systems
- Experience with Process Validation and Cleaning Validation activities
- Experience handling OOS/OOT investigations and CAPA processes
- Experience with APQR and stability oversight
- Excellent English communication skills (written and spoken)
- Ability to prioritize tasks and meet deadlines; strong project management skills
- Effective problem solving, initiative and creativity
What We Do
Pharmathen is a research-centered, pharmaceutical company focused on developing and marketing innovative generic products and complex drug delivery technologies, aiming to provide Life Cycle Management solutions.
