Senior Associate Qa Gmp

Senior Associate QA (GMP) – Breda Orion Group Life Sciences are currently recruiting a Senior Associate QA (GMP) on behalf of our Multinational Biopharmaceutical Client based in Breda , on an initial 12-month contract with potential to extend. Shift Structure Please note: This is a 3-shift position , following the rotation below: Week 1 – Night Shift Week 2 – Late Shift Week 3 – Early Shift Week 4 – Late Shift Week 5 – Early Shift Shift Times: Early Shift: 06:30 – 15:00 Late Shift: 14:30 – 23:00 Night Shift: 22:30 – 07:00 Important: Please thoroughly discuss the shift structure with candidates. 100% commitment to the shift pattern is required. Objectives & Responsibilities Provide QA guidance and support within the production area at ABR. Perform batch record reviews of batches assembled, packaged and labelled at ABR. Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management, and the Qualified Person (QP). Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures (SOPs) and Work Instructions. Act as the first point of contact for quality-related production queries during packaging and labelling operations. Review and approve batch production record data entries before production activities take place. Perform finished product checks during commercial production runs. Compile and review batch records for lots assembled, packaged and labelled at ABR in preparation for disposition by the QP. Perform GMP compliance checks within production. Review and approve deviation records. Initiate and own QA deviations as required. Act as an author for operational SOPs and Work Instructions, as required. Review operational SOPs and Work Instructions, as required. Assist in the development and delivery of GMP training activities for QA and Production staff. Participate in QA production-related projects, as required. Assist with various investigations, as required. Assist with ABR projects and continuous improvement efforts, as required. Prepare weekly and monthly metrics. Own and maintain departmental performance boards. Minimum Requirements MSc or BSc degree in Pharmaceutical Sciences, Life Sciences, or a related field, or an equivalent combination of education and relevant experience. Typically 3+ years of relevant Quality Assurance or manufacturing experience within the pharmaceutical or medical device industry, including experience with batch record review and investigations . Knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/or Good Clinical Practice (GCP) , with the ability to interpret and apply relevant requirements in mainly routine cases. Experience with Manufacturing and/or Quality analytical processes and operations . People are our business worldwide Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.