Jobid=638681347322679032 (0.0498)
Bedrijfsomschrijving
You
will join an international organization within the pharmaceutical
and life sciences sector. Every day, teams work on products,
processes, and systems that must meet strict quality standards and
GMP requirements. The organization invests heavily in innovation,
knowledge development, and collaboration across disciplines.
Within this professional environment, you will
have the opportunity to contribute to challenging validation and
compliance projects while playing an important role in maintaining
the quality of processes and installations.
Working hours
You
will work during standard office hours.
Functieomschrijving
Would
you like to play a key role within a GMP-regulated environment
where quality, compliance, and validation are at the heart of every
process? Do you have extensive experience with qualification and
validation projects and thrive in an environment where accuracy and
quality make the difference? Then this position as QA
Validation Specialist in Maastricht
could be the next step in your career.
In this role, you will be responsible for reviewing,
approving, and overseeing validation and qualification activities
within an international pharmaceutical and life sciences
organization. You will work closely with colleagues from QA,
Engineering, Production, and Technical Services and make a direct
contribution to ensuring quality, safety, and regulatory
compliance. For professionals with the right experience, this
position offers a challenging environment with significant
responsibility and impact.
As a QA
Validation Specialist, you ensure that equipment, facilities,
utilities, and processes comply with GMP guidelines, internal
procedures, and applicable regulations.
Your responsibilities include:
- Reviewing and approving validation and qualification
documentation (DQ, IQ, OQ, and PQ) - Assessing
and approving User Requirement Specifications (URS) - Preparing, reviewing, and maintaining
validation and qualification plans - Performing
and evaluating risk assessments for equipment, facilities, and
utilities - Approving FAT, SAT, commissioning,
and validation reports - Ensuring full
traceability throughout validation projects - Managing and reviewing lifecycle documentation
for equipment and installations - Conducting
periodic reviews of validated GxP systems, equipment, and utilities - Performing impact assessments for changes to
equipment, facilities, and processes - Supporting production and technical
departments with validation activities - Managing deviations, change controls, and CAPA
processes - Ensuring compliance with GMP, GxP,
GDP, and quality requirements - Providing advice
on quality and compliance-related matters - Identifying and implementing improvements
within validation and quality systems - Collaborating with QA, Engineering,
Production, and Technical Services to ensure compliance
What’s in it for
you
- Gross monthly salary
between €4,500 and €7,000 - Temporary employment
contract through Manpower - Travel allowance of
€0.23 per kilometer - Pension accrual
- Full-time position of 40 hours per week
- Opportunity to work on high-level projects
within the pharmaceutical and life sciences industry - Significant responsibility within complex
validation and compliance processes - Collaboration with experienced specialists
across multiple disciplines - Room for
professional and technical development - Working
environment focused on quality, knowledge sharing, and continuous
improvement
Functie-eisen
- Bachelor’s or Master’s degree in Engineering, Life
Sciences, Biology, Biomedical Sciences, or a comparable field - At least five years of experience within a
GMP- or GxP-regulated environment - Experience
with Qualification & Validation activities (DQ, IQ, OQ, and PQ) - Knowledge of cGMP, GDP, GAMP, and validation
methodologies - Experience with deviations,
CAPAs, and change control processes - Experience
with equipment, facility, and utility validation - Excellent command of the English language,
both written and spoken - Experience with
quality management systems and compliance requirements within the
pharmaceutical or life sciences industry
Preferably, you also have:
- Strong analytical and problem-solving skills
- Accurate and quality-focused working style
- Ability to work independently and take
ownership - Excellent communication skills
- Strong stakeholder management capabilities
- Strong organizational skills and the ability
to manage multiple projects simultaneously - Proactive and results-oriented mindset
- Experience with process optimization and
continuous improvement initiatives - Strong
collaboration skills within multidisciplinary teams - Ability to prioritize effectively in an
environment with multiple ongoing projects
Are you the QA Validation Specialist ready for a new
challenge in Maastricht? And would you like to apply your expertise
in validation, compliance, and GMP within a professional
organization where quality comes first? Then apply
today.
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