- Manage and execute Quality System processes and programs such as change control, internal audits, LIMS administration, vendor & supplier qualification, and other related responsibilities.
- Serve as a key point of contact for client and authority inspections, ensuring readiness and managing post-audit follow-ups.
- Ensure compliance with GDP regulations and best practices, maintain a compliant quality system including document control, and oversee record management.
- Lead action plans and risk assessments for potential nitrosamine contamination.
- Represent Quality Systems in Project Leadership Teams for new product introductions.
- Perform and manage Responsible Person (RP) duties for controlled drugs on site.
Requirements - Preference will be given to candidates with a degree in Pharmacy.
- Excellent communication skills and fluency in written and spoken English are essential.
- Attention to detail is critical, with the ability to work independently and part of a team.Education and Experience
- A tertiary level of education in life sciences or a related field, with preference given to Pharmacists.
- Preferably with 2-3 years of previous related experience in quality and/or systems within the pharmaceutical sector.
- Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution.Benefits
- Performance Bonus
- Health Insurance
- Other Benefits
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Quality Systems Senior Specialist - Malta - Konnekt
Description
We are seeking to recruit a Quality Systems Senior Specialist to strengthen our Quality Systems & Compliance section within the Quality Department. This candidate will also be supporting with any RP roles when needed.
Responsible:
