Senior Pharmaceutical Specialist - Quality & Tech Transfer

MSD Malaysia; Haarlem; Vor Ort; EUR 75.000 - 105.000; Vollzeit

Benefits dieser Stelle

3% year-end bonus

Annual leave 35.5 days

Travel expense reimbursement

Pension plan

On-site restaurant

On-site sports facilities

Quality-focused culture

Lyra Health wellbeing

Zusammenfassung

Merck & Co., Inc., Rahway, NJ, USA (Merck Sharp & Dohme LLC) in Haarlem seeks a Senior Pharmaceutical Specialist to guide device assembly, packaging processes and technology transfers under GMP in a highly regulated environment.

You will partner with production, quality, technical operations and global teams to manage product quality risks, drive investigations, change controls and continuous improvement while ensuring compliance with regulatory standards and company policies.

Qualifikationen

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related.
• 3–5 years' experience in pharmaceutical manufacturing, preferably device assembly/packaging/tech transfer.
• GMP-regulated environment experience; ISO 13485 is advantageous.
• Strong knowledge of QA, GMP compliance, regulatory requirements, standards and quality management systems.
• Experience with technical investigations, change control, quality risk assessments and continuous improvement initiatives.
• Ability to analyze complex technical and quality-related issues and translate findings into practical recommendations.
• Conversational Dutch language skills and ability to engage cross-functionally.

Aufgaben

• Advise IPT and Centre of Excellence leadership on pharmaceutical and technical topics.
• Identify, assess and manage product quality risks in line with GMP and regulatory requirements.
• Translate external guidelines into relevant pharmaceutical policies and procedures.
• Author, review and approve GMP documentation including process control, investigations and changes.
• Lead or contribute to the resolution of complex technical and product quality issues using expertise and data analysis.
• Facilitate or participate in Quality Risk Assessments with mitigations.
• Support GMP inspections and ISO 13485 audits with cross-functional collaboration.
• Drive continuous improvement initiatives and change control activities in a regulated environment.
• Contribute to training programs and foster a quality-focused culture.

Kenntnisse

GMP compliance

Quality assurance

Change management

Investigation & analysis

Cross-functional collaboration

Dutch language

Strong communication

Ausbildung

Bachelor’s or Master’s in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related

Jobbeschreibung

Merck & Co., Inc., Rahway, NJ, USA (Merck Sharp & Dohme LLC) in Haarlem seeks a Senior Pharmaceutical Specialist to guide device assembly, packaging processes and technology transfers under GMP in a highly regulated environment.

You will partner with production, quality, technical operations and global teams to manage product quality risks, drive investigations, change controls and continuous improvement while ensuring compliance with regulatory standards and company policies.