QA Specialist Validation / Engineering
- Noord-Brabant
- 4000.00 - 6000.00
- 32-40 hours
- Project duration at least a year
- Master degree
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry.
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry. They participate in interesting projects in the pharmaceutical industry. They do this by providing support to clients on challenging and varied projects. Usually with the opportunity for personal development in addition to your contribution.
Requirements
- Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent.
- 5-8 years of professional experience in GMP environment.
- Relevant experience in Equipment and Automation Validation.
- Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
- Proven experience with risk management tools such as FMEA, etc.
- Proven experience with statistical tools to support e.g. sampling plans and hypothesis testing.
- Experience with Nonconformances, CAPAs and Change Control.
What do you get?
- Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
- Collective WGA / WIA insurance
- NBBU collective labour agreement through equal remuneration
- 25 holidays days
- 8% holiday allowance
- 100% payment in case of illness in the first year
- Travel allowance per kilometer or through public transport
Duties
- Perform QA support and oversight for validation of equipment, automation and information systems and for Quality Risk Management.
- Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
- Provide guidance and direction to operations staff in regards to compliance with quality policies, standards and procedures.
- Provide quality engineering support for testing strategies and quality investigations.
- Review and approves validation documentation. changes to equipment and M&E procedures.
- Represent QA in QRM activities (pFMEA, QRAES, Computer system compliance)
- Ensure alignment of site Quality Risk activities with corporate policy and strategy.
- Review quality risk assessment summary reports.
- Perform final review of technical change controls.
TAGCLOUD
qualityassurance#GMP
#engineering
#validation
#pharma
#QRM
#changecontrol
