Senior QA Officer
For an international pharmaceutical client in Flevoland I am looking for a Quality Assurance (QA) officer, specialized in quality assurance on the shop floor. In this role you will support the organization in handling quality matters and participate in the set up, maintenance and improvement of quality related processes. You will be responsible for review of GMP related documents such as batch records, procedures, work instructions as well as related change controls, CAPAs and deviations.
What are your responsibilities?
* Reviewing of batch documentation on the shop floor will be a substantial part of the job;
* Handling of deviations, CAPA's and change controls
* Supporting production departments with GMP related projects on the shop floor, such as roll-out of data integrity, preparation for regulatory inspection and GMP improvement projects;
* Ensuring appropriate and lean implementation (aligned with corporate QA policies and regulations) of new GMP systems together with production departments;
* Reviewing and approving GMP documentation such as validation protocols and reports, risk assessments, procedures, work instructions; all in line with the applicable corporate procedures and policies;
* Reviewing regulatory submission documents
* Writing and maintenance of work instructions and SOPs for the biopharmaceuticals organization, when needed;
* Performing internal and external audits of departments and suppliers respectively.
What skills do you bring?
* MSc level of experience and education in Life Sciences (e.g. Biotechnology, Bioprocess engineering or related);
* A minimum of 3 years work experience in the pharmaceutical industry in a cGMP environment; in combination with relevant quality experience, e.g. QA, Production, Process Development, Technical Operations
* Experience with cell culture and downstream processing operations is key
* Knowledge of GMP guidelines and regulations in the scope of biopharmaceutical industry;
* Excellent verbal and written communication skills in both Dutch and theEnglish language.
* Experience in transferring
* Competitive salary range
* Start date: ASAP
* Location: Almere
* Contract: 6 months
Are you available per direct and would you like to apply for this position? Please do not hesitate to contact Celine Stevens by sending an email to c.stevens[at]realstaffing.com or call 020 522 1588.