For our client, a company in biopharmaceuticals, we are looking for a Senior QA Associate based in Brabant.
Within the QA team you will provide QA guidance and support in the production area at ABR. You will also perform batch record review of batches assembled, packaged and labeled at ABR and contract manufacturers. Furthermore you establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
- Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions;
- Act as a first point of contact in case of production queries (quality related) during packaging and labeling 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 labeled at ABR and contract manufacturers in preparation for disposition by QP;
- Review of operational SOP's and Work Instructions as needed;
- Review and approve deviation records;
- Initiate and own QA deviations as needed;
- Perform GMP compliance checks in production;
- Assist in development and delivery of GMP training activities for QA and production staff;
- Participate in QA production related projects as needed;
- Assist in various investigations as needed;
- Assist in ABR projects and improvement efforts as needed;
- Responsible for preparation of weekly/monthly metrics;
- Own and maintain departmental performance boards.
- MBO or Bachelor's degree in Life Sciences or related field or the equivalent combination of education and/or experience;
- Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations;
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases;
- Manufacturing and/or Quality analytical processes and operations;
- Words that characterize you: hands-on, result orientated, self-starter, proactive behavior, problem solving, flexibility.
What do we offer
- Contract via Kelly Services of 6 months (40 hours per week), possible extension;
- Please note: this is a 3 shift job. Early shift: 06.30 - 15.00 Late shift: 14.30 - 23.00 Night shift: 22.30 - 07.00. Shifts will be compensated through extra shift allowance;
- Start date: January 2021;
- An international environment where you can learn a lot in challenging projects.
T: 06 - 33 13 77 46
When interested please react through the application process with your English resume.
About Kelly Services
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.