Senior Production Expert

SIRE LIFE SCIENCES; Haarlem; On-site; EUR 60,000 - 90,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a Pharmaceutical Production Quality Specialist to maintain and enhance QA processes in pharmaceutical production, ensuring GMP compliance and adherence to company protocols.

The role focuses on overseeing QA activities across bulk manufacturing and packaging, addressing deviations, and driving continuous improvements in production methods and technology.

Qualifications

• Master’s degree or equivalent in Pharmacy, Chemical Engineering, or related field.
• Strong knowledge of aseptic pharmaceutical processes and GMP.
• Experience in a pharmaceutical production environment.
• Excellent communication, analytical, planning, and organizational skills.
• Proficiency in English (spoken and written).

Responsibilities

• Oversee and support quality assurance activities in production, including bulk manufacturing and packaging.
• Assist with deviations, quality issues, and timely resolution with production.
• Evaluate pauses in production in response to deviations and drive decisions.
• Develop and implement improvements in production methods and technology.
• Provide technical support on quality topics and investigate root causes.
• Document CAPAs, investigate complaints, and close quality incidents.
• Support continuous improvement initiatives based on audits and deviations.
• Ensure GMP compliance by reviewing SOPs, validation protocols, batch records.
• Support training, knowledge transfer, and quality/compliance projects.
• Collaborate with production management, QA, operators, and external partners.

Skills

Quality assurance

GMP compliance

Production control

Communication

Analytical skills

Planning

Organizational skills

Team collaboration

Education

Master's degree in Pharmacy

Master's degree in Chemical Engineering

Job description

Company:

A leading organization in the pharmaceutical industry dedicated to ensuring the highest standards of quality and safety in drug manufacturing. The company is committed to continuous improvement, compliance, and innovation within its production facilities.

Job Description:

We are seeking a dedicated Pharmaceutical Production Quality Specialist to join our client's team. The successful candidate will play a key role in maintaining and enhancing quality assurance processes within pharmaceutical production, ensuring compliance with GMP standards and company protocols.

Responsibilities:

• Oversee and support all quality assurance activities within the production environment, including bulk manufacturing and packaging operations.
• Assist with handling deviations, quality issues, and supporting production to resolve them effectively.
• Evaluate whether production processes should be paused in response to deviations and ensure timely decisions are made.
• Contribute to the development and implementation of improvements in production methods and technology.
• Provide technical support on quality topics, monitor production processes, report deviations, and investigate root causes.
• Document and manage CAPAs, investigate complaints, and ensure proper closure of quality incidents.
• Develop and implement continuous improvement initiatives based on audit observations, deviations, and industry best practices.
• Ensure compliance with GMP standards by reviewing SOPs, validation protocols, batch records, and related documentation.
• Support ongoing training, knowledge transfer, and participation in quality and compliance projects.
• Engage with internal teams such as production management, QA, operators, and external partners as needed.

Requirements:

• Master’s degree or equivalent in Pharmacy, Chemical Engineering, or a related field.
• Strong knowledge of aseptic pharmaceutical processes, GMP, and production control systems.
• Previous experience in a pharmaceutical production environment is essential.
• Excellent communication, analytical, planning, and organizational skills.
• Proficiency in English, both spoken and written.
• Ability to work effectively in a fast-paced, dynamic environment with a results-oriented approach.
• Strong team player with a collaborative mindset and a focus on quality.