Senior Quality Assurance Specialist and Compliance Expert
6 ore fa
Antal International Network is seeking a highly skilled Senior Quality Assurance Specialist and Compliance Expert to lead quality-related initiatives and ensure compliance with regulatory requirements in the Pharmaceutical industry.
OverviewA challenging role has arisen for a Senior Quality Assurance Specialist and Compliance Expert to join a Multinational Pharmaceutical company based in Milano Ovest, Italy. The successful candidate will be responsible for managing batch disposition processes, ensuring timely product release, and maintaining compliance with site practices and regulatory requirements.
Responsibilities- Batch Disposition Management: Manage batch disposition processes to ensure timely product release, including close coordination with cross-functional teams to resolve product deviations prior to batch release.
- Compliance and Regulatory Affairs: Maintain compliance with site practices and regulatory requirements, supporting major investigations and resolving product deviations in a timely manner.
- Team Collaboration: Participate in cross-functional teams as Quality/Qualified Person representative, contributing to team success through effective communication and problem-solving skills.
- Postgraduate Qualification: A postgraduate qualification (MSc or equivalent) is required for this role.
- cGMP Experience: 8+ years of cGMP experience with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA).
- Leadership Skills: Proven leadership skills with 2+ years of management responsibility, demonstrating ability to motivate and lead high-performing teams.
- Problem-Solving Abilities: Strong problem-solving, risk assessment, and impact analysis abilities, with experience in managing Health Authority audits, CAPA plans, and related documentation.
- Training and Mentoring: Training and mentoring experience, with ability to develop and implement training programs to enhance team performance.
- Effective Communication: Excellent written and verbal communication skills, with ability to articulate complex technical information to non-technical stakeholders.
We estimate the salary range for this role to be approximately €120,000 - €180,000 per annum, depending on experience and qualifications.
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