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Client:
Galenicum
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Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
135198544341080473632460
Job Views:
6
Posted:
31.03.2025
Expiry Date:
15.05.2025
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Job Description:
We are looking for a Quality Assurance Manager. The responsibilities include:
* Maintaining and updating QA systems and SOPs based on current procedures.
* Managing suppliers, including evaluations.
* Organizing and conducting internal audits.
* Proposing and managing corrective actions for continuous improvement.
* Managing validations (transport, software) and overseeing Validation Master Plan.
* Staying updated on GMP regulations and assessing their impact.
* Leading GMP/GDP training across the company.
* Ensuring GMP requirements and quality standards are understood and maintained.
* Possessing strong knowledge of EudraLex Volume 4-cGMPs, GLP, and FDA Guidelines.
* Experience implementing Quality Systems in GMP environments and with Health Authority Inspections.
* Proficiency in MS Office, SAP, and TrackWise or similar platforms.
Education:
* Degree in Pharmacy or Life Sciences.
* Master’s degree in Pharmaceutical Industry or related field.
* Fluent in English and Spanish, both spoken and written.
* Auditor training and experience.
Skills:
* Motivated, disciplined, proactive, dynamic, methodical, organized, and decisive.
* Self-sufficient with leadership and management skills.
* Strong analytical and troubleshooting skills.
* Responsible and capable of working under pressure to meet deadlines.
* Ability to prioritize multiple tasks.
* Good team player with collaborative working style.
* Excellent organizational, planning, and time management skills.
* Detail-oriented with strong communication skills.
* Experience in report writing, including risk assessments and audit reports.
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