Pharmaceutical Quality Assurance Specialist
vor 1 Woche
We are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our team at UCB.
About the RoleThis role is responsible for ensuring compliance with national and international regulations, guidelines (GMP), and relevant UCB Quality Policies in operations related to products delivery.
- Provide quality support from start to finish for product(s) in charge, including management of activities and processes related to deviations, OOS, CAPAs, Change Control, Complaints, Equipment's/Utilities/Environment qualification, Process/Cleaning validation, Product Quality Review, Continuous Process Verification, Master data activation, GxP documentation.
- Establish and maintain relationships with internal/external customers/stakeholders to provide efficient follow-up of product related to deviations, change controls, investigations, incidents, CAPA, complaints, etc.
- Enforce Compliance of stakeholders related to relevant product flow, UCB standards, and GxP.
The ideal candidate will have a Master's degree in Life Sciences or an equivalent working experience, with a minimum of 3 to 5 years of experience in manufacturing, laboratory, quality assurance/control, regulatory affairs.
Key Responsibilities- Coordinate multifaceted projects and meet critical deadlines.
- Work independently under tight and shifting priorities.
- Collaborate closely with operational teams in manufacturing and laboratory areas.
- Negotiate and convince effectively.
- Develop and maintain written communication capabilities with diverse groups and/or individuals and/or functions.
- Demonstrate technical competence in core areas of pharmaceutical product manufacturing.
- Produce high-quality scientific/technical documents.
- Communicate fluently in English.
- Master's degree in Life Sciences or an equivalent working experience.
- A minimum of 3 to 5 years of experience in manufacturing, laboratory, quality assurance/control, regulatory affairs.
- Excellent negotiation and convincing skills.
- Well-developed sense of discretion.
- Demonstrated oral and written communication capabilities with varying, culturally diverse groups and/or individuals and/or functions.
- Demonstrated understanding of the GxP environment and technical competence in core areas of pharmaceutical product manufacturing.
- Demonstrated ability to write up scientific/technical documents.
- Excellent oral and written communications skills in English.
$80,000 - $110,000 per year, based on location and experience.
BenefitsWe offer a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.
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