QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products.
This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products, raw material batches if required and maintaining working relationships with QA departments at contract facilities. The position will support on the floor QA activities (deviation, CAPA, OOS, change control, batch release, archiving, complaints …) Couvet site included work in 2*8 shift if required. As a member of Quality Operations team, this position will be expected to be reliable source of information and interpretation of quality and cGMP compliance requirements. Furthermore, the position holder is responsible to identify and handle packaging, warehouse, or bulk/QC and cGMP compliance related issues. Additional tasks are quality metrics, risk assessments, as well as the support of health authorities’ inspections and corporate audits.
This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, ensure lean release of finished/semi-finished product, bulk product, or raw materials for production, as well as to contribute to process improvement in his/her scope of activity.
****This is a Long Term Temporary Position*****
Experience / Education
Knowledge / Skills / Abilities:
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
The position holder is responsible and accountable for the tasks given below. The list of tasks is non- exhaustive, according to business needs other tasks might be assigned to the position holder.
The position holder:
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