We are currently seeking a “QA Senior Specialist and RP Deputy” to join our team in Romania for a fix-term period of two years (maternity cover). This is an exciting opportunity for a motivated and experienced professional to play a critical role in ensuring compliance with our Quality Management System (QMS) and contributing to our mission of delivering excellence in healthcare.
Position Purpose
As the “QA Senior Specialist and RP Deputy”, you will be responsible for maintaining the Quality Management System (QMS) of Angelini Pharmaceuticals Romania SRL, ensuring compliance with local, EU, and global Angelini Pharma standards. You will oversee all Quality Assurance (QA)-related tasks at the affiliate level and support International QA and R&D QA departments in implementing and maintaining quality compliance.
Key Responsibilities
On Quality Management System (QMS):
- – Maintain quality management system in compliance with EU and national regulations as well as Angelini Pharma’s global standards.
- – Ensure local compliance with applicable regulations, policies, and procedures with the support of HQ QA and International QA.
- – Represent the affiliate in all quality-related matters, including interactions with local authorities.
- – Provide oversight for key processes, equipment qualification, validation, and computerized systems to ensure compliance.
- – Manage the affiliate’s quality documentation, including review, approval, and archiving of GxP-related documents, and ensure records’ integrity and retention.
- – Handle deviations, non-conformities, complaints, CAPAs, and change controls through applicable quality systems and tools.
- – Monitor local regulations, legislation, and standards, and ensure timely adaptation of processes to align with global and local requirements.
- – Coordinate and host inspections and audits (if any).
– Provide local quality inputs for product dossiers or other regulatory requirements. – Act as the Training Lead, managing training processes and systems in line with regulatory and QMS requirements.
– Serve as the Risk Assessment Coordinator for the local quality risk management process
– Provide quality support to the Country Manager and other functions in the affiliate.
– Collaborate with global and local stakeholders to ensure compliance and optimize processes.
– Act as the back-up for the Responsible Person (RP) when required.
– Perform other role-relevant tasks as needed by management to support business operations.
Pharmacovigilance (PV) Support:
- – Maintain a QA PV system, managing training, documentation, and quality events.
- Support pharmacovigilance activities through oversight of local PV processes, reporting safety information to the PV function, and ensuring reconciliation of data.
- – Act as a key contact for Global GVP QA and assist during Health Authority inspections or internal/external audits related to pharmacovigilance.
Qualifications & Requirements
We are looking for a detail-oriented, proactive, and committed professional with the following qualifications:
Education: Bachelor’s or Master’s degree in Pharmacology,
Experience: Minimum of 2 years of experience in the pharmaceutical sector, better if with Good Distribution Practices (GDP) field.
Language Skills: Romanian (native), English (fluent)
Competencies:
- – Strong understanding of quality assurance principles and quality management systems (QMS).
- – Familiarity with EU and local regulations governing medicinal products and pharmacovigilance processes.
- – Proficient in handling quality documentation and computerized systems.
- – Excellent communication skills and ability to liaise effectively with internal and external stakeholders, including regulatory authorities.
- – Highly organized, analytical, and capable of working independently while managing multiple responsibilities.
- – Strong problem-solving skills with a focus on continuous improvement.
