Senior Manager of Compliance overseeing compliance operations related to insurance regulations at Tokio Marine HCC. Leading a team to ensure adherence to regulatory standards and internal guidelines.
About the role
- QMS & Compliance Officer at Pharmathen Pharmaceuticals, overseeing Quality Management System and ensuring compliance. Engaging in audits, training, document control, and cross-functional collaboration.
Responsibilities
- 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
- 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
- Keep a key role in customer audits and authorities’ inspections and corresponding Capa Plan management
Requirements
- Educational background in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
- 1-3 years’ experience in Quality Management (desirable)
- **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
- 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.**
Job title
Job type
Experience level
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