6 дней назад
Manager QA (Pharmaceutical GMP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager QA (Pharmaceutical GMP): Leading plant Quality Assurance staff and providing real-time quality oversight for pharmaceutical manufacturing operations with an accent on GMP compliance, batch documentation, investigations, and risk-based decision-making. Focus on approving deviations and CAPA records, supporting audits and inspections, resolving recurring quality events, and enabling timely batch disposition.
Location: Breda, Netherlands; on-site role
Company
is a biotechnology company developing, manufacturing, and delivering medicines to patients worldwide.
What you will do
- Lead and direct Quality Assurance staff supporting production operations during shifts, including resource planning, performance management, and staff development.
- Provide real-time QA oversight and guidance to Production, Maintenance & Engineering, and Quality teams on quality standards and procedures.
- Review and approve cGMP documentation, including deviations, CAPAs, electronic batch records, change controls, design qualifications, and SOPs.
- Lead or support quality and compliance investigations, resolve operational issues, and alert senior management to quality, supply, compliance, and safety risks.
- Participate in internal audits, regulatory inspections, and partner audits.
- Drive Lean Transformation, Operational Excellence, continuous improvement, and reduction of recurring events; support batch review and disposition activities.
Requirements
- Master of Science degree in Pharmacy or an equivalent qualification, or another Master’s degree supplemented with relevant pharmaceutical GMP experience.
- Typically 2+ years of practical experience in clinical or commercial GMP manufacturing, warehousing, supply chain, equipment engineering principles, and validation.
- Ability to solve problems and make scientific, risk-based decisions.
- Strong written and verbal communication skills, including technical writing and presentations.
- Ability to collaborate effectively with production and technical staff.
Nice to have
- Knowledge and skills aligned with EU Directive 2001/83/EC Article 49 requirements for a Qualified Person.
- Knowledge of GDP Guidelines 2013/C 68/01, Chapter 2.2, for a Responsible Person.
- Ability to execute batch disposition or fulfill Qualified Person duties.
Culture & Benefits
- Opportunities for professional development and career progression across a global organization.
- Diverse and inclusive workplace where employees can contribute ideas and take action.
- Competitive salary, bonus structure, fixed 13th-month payment, holiday allowance, and collective health insurance.
- On-site gym, vitality program, and restaurant offering healthy food.
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