Senior Associate QA
Senior Associate QA in Breda, Noord-Brabant, voor een wereldwijde farma- en life sciences organisatie, tijdelijke functie.
- Locatie
- Breda
- Werkvorm
- op locatie
- Sluitingsdatum
Eisen
- Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience
- Excellent communication and stakeholder management skills
- Knowledge of GMP, GDP, and/or GCP regulations
- Experience working within regulated pharmaceutical or medical device environments
- Fluent English & Dutch language skills
- Bachelor degree or equivalent qualification in Life Sciences or a related field
- Ability to work effectively under pressure
Wensen
- Experience with SAP Master Data processes is advantageous
Volledige omschrijving
The Company: A global organization operating within the pharmaceutical and life sciences industry, focused on maintaining high quality standards across manufacturing, supply chain, and regulatory processes. The company works in a highly regulated environment where compliance, product quality, and patient safety are critical priorities.
About the Role: The NL CW Senior Associate QA is responsible for supporting Quality Assurance activities related to SAP Master Data and artwork approval processes. The role ensures compliance with GMP requirements while maintaining data integrity and operational excellence. This position works closely with cross functional teams including regulatory affairs, supply chain, master data specialists, and quality management to support business objectives and continuous improvement initiatives.
Responsibilities: Perform QA review and approval of SAP Master Data activities including critical value verification and Bills of Materials; Review and approve artwork for medicinal products; Author operational SOPs and Work Instructions; Conduct QA review of SOPs and Work Instructions; Participate in Quality Assurance projects and continuous improvement initiatives; Support investigations and issue resolution activities; Prepare weekly and monthly quality metrics reports; Own and maintain departmental performance boards; Monitor QA systems and recommend improvements; Collaborate with Global Artwork Center, Master Data teams, Site SMEs, Regulatory Affairs, and QA Management; Identify, evaluate, and resolve data integrity issues; Ensure compliance with regulatory and quality standards.
Requirements: Bachelor degree or equivalent qualification in Life Sciences or a related field; Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience; Knowledge of GMP, GDP, and/or GCP regulations; Experience working within regulated pharmaceutical or medical device environments; Excellent communication and stakeholder management skills; Ability to work effectively under pressure; Experience with SAP Master Data processes is advantageous; Fluent English & Dutch language skills.
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