QMS & Compliance Senior Officer
Pharmathen
Job Type
Description
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 a QMS & Compliance Senior Officer to join our Quality Management System (QMS) at our Pallini premises.
Requirements
More particularly:
What you will do:
- 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
- Conduct regular audits and inspections to monitor compliance with QMS principles and regulatory requirements as well as Regulatory compliance, identifying areas for improvement and ensuring corrective actions are implemented
- Provide training and guidance to staff on QMS procedures, compliance obligations, and quality assurance best practices
- Ensure the compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and EU cGMPs
- Communicate with customer regarding any quality queries related with the activities of the facility
- Participate in multidisciplinary team for performing investigations
- Collaborate with cross-functional teams to ensure alignment on quality and compliance objectives and to foster a culture of quality across the organization
- Follow Company's Quality Policy and comply with current operational standards and legislative requirements
- Ownership of Document Management, Training system, Audit management including Self Inspection, Risk Management, Escalation process, Complaints management, CAPAS, as well as other Quality Management System policies, Regulatory compliance activities and Data Integrity related activities
- Active participation in SOPs and Master Records preparation/review, Deviation handling, Change Management, OOS/OOT investigations, utilities/environmental monitoring, various statistical evaluations, APQR, Process Validations, Cleaning Validations, Aseptic process Simulations, KPIs monitoring, stability oversight as well as various transfer, engineering and CSV projects and Data Integrity Campaign
The ideal candidate should have:
- Educational background in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
- 3-5 years’ experience in Quality Management (necessary)
Job-Specific Skills:
- Excellent communication in English language (writing & speaking)
- Broad knowledge and extensive experience on pharmaceutical quality systems
- Extensive knowledge of European GMPs in order to be able to ensure compliance with national and European standards and legislation
- Ability to prioritize tasks and meet deadlines
- Effective problem solver
- Strong initiative and creativity skills
Benefits
What 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.
This job is found at InterviewStack.io