Company:
Our client is a well-established life sciences manufacturing site in the Breda area, operating in a highly regulated GMP environment. The business is growing quickly, which means a fast-paced production setting, close cross-functional collaboration, and a strong focus on doing things right first time.
Job Description:
We are looking for a Senior Quality Assurance Associate to provide hands-on QA support on the shop floor, with a strong focus on packaging and labelling. This is a dynamic role where the successful candidate will be the key quality point of contact for Production, helping to resolve issues in real time while ensuring full GMP compliance. The role also includes batch record review, finished product checks during production, and supporting investigations and deviations.
Responsibilities:
• Act as the main QA point of contact for Production during packaging and labelling operations, answering quality-related questions and supporting daily decision-making
• Provide on-the-floor quality oversight during production and perform routine GMP compliance checks
• Review and approve batch record entries before production activities take place and compile/review completed batch records for disposition preparation
• Perform finished product checks during commercial production runs
• Review, approve, initiate, and own deviations as required, and support investigations when issues occur
• Support continuous improvement by contributing to production-related QA projects and site improvement initiatives
• Write, review, and update operational SOPs and work instructions where needed
• Support GMP training activities for QA and Production teams
• Prepare weekly/monthly quality metrics and maintain departmental performance boards
• Build strong working relationships with Production, Warehouse, Maintenance, Engineering, QA Management, and the Qualified Person
Requirements:
• BSc or MSc in Pharmaceutical Sciences, Life Sciences, or a related field (strong academic background preferred)
• Around 3 years’ experience in Quality Assurance and/or manufacturing within pharma or medical devices (flexibility for strong recent MSc graduates or relevant internships)
• GMP knowledge is preferred (QA experience in a GMP setting is an advantage but not strictly required); candidates with a QC background are also welcomed
• Experience with batch record review and supporting investigations/deviations is highly beneficial
• Fluent English
• Strong communication, problem-solving, and decision-making skills; able to stay calm under pressure and handle resistance professionally
• Willing to work shifts and fully commit to the current 3-shift rotation and the planned future 5-shift rotation
• Able to commute within approximately 1 hour by car
Other Information:
This position is based on-site in Breda and requires full commitment to shift work. The current schedule is a 3-shift rotation (early/late/night). A transition to a 5-shift rotation is planned from 01/01/2027 at the earliest, so only candidates who are willing and able to work the future pattern will be considered.
If you are interested and want to apply, please submit your application via the apply button below and contact me.
58719
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Manideep Rachakonda
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