Our client is a world leader in the pharmaceutical sector, particularly around the production of Active Pharmaceutical Ingredients (API) as well as in Contract Development and Manufacturing. Although headquartered in Italy, they also have a number of operations across Europe, Asia and North Africa.
Currently, the company is looking for an experienced QA Technician to join their team in one of their production plants in Murcia, Spain.
— MISSION —
This position will actively assist the QA team with their daily duties including inspection, batch records, document and record control, and shipping requirements. The successful candidate will provide support to the plant staff and guarantee that all the operations are in compliance with the necessary/mandatory regulations.
— RESPONSIBILITIES —
- Collaborate closely with other teams, both internally and externally, across various CMO/CDMO projects;
- Participate directly in conversations with customers and manage all requested information/documentation;
- Assist with writing and/or review of protocols, reports, data and supportive documentation as needed to ensure full compliance with commitments;
- Manage deviations and non-compliance system in order to ensure that all defined activities are performed;
- Assist in managing all regulatory activities related with the new products, updating of existing documents, deficiency letters, etc.;
- Perform and oversee component or product inspection, sampling, analyses following standard methods and procedures, and approval/release;
- Conduct reviews of batch documentation for GMP Compliance. Work with production personnel to resolve GMP discrepancies. Establishe files for batch documentation;
- Maintain knowledge of all procedures and changes to specification related to areas of responsibilities;
- Store, record and maintain electronic and hard copies of controlled documents and records;
— REQUIREMENTS —
- Bachelor’s degree, preferably in Chemistry or Pharmacy;
- Previously 3+ years of experience working in Quality Assurance, ideally for a chemical –pharmaceutical company;
- Detailed knowledge of GMP practices;
- Ability to work both independently and as part of a multidisciplinary team;
- Excellent interpersonal skills, strong orientation towards problem solving and timely achievement of objectives; organised and a self-starter;
- B2 level of English (written and spoken).
Please submit your application via the following email address: firstname.lastname@example.org quoting the job title in the subject.