Incoming Quality Control Analyst is required for the sampling and testing of packaging material for the Secondary Packaging facility and raw materials for the new Purification and Aseptic Manufacturing plant for blood protein Albumin in Grifols Worldwide Operations (GWWO).
This role offers a chance to work in a state-of-the-art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus. Reporting directly to the Incoming Quality Control (QC) Assistant Manager of Grifols Worldwide Operations (GWWO).
*Perform sampling of raw materials/packaging materials in non-classified and cleanroom environment as required
*Perform testing of raw materials/packaging materials as per procedures and as required per the Production plan
*Ensure all Laboratory equipment used is maintained, calibrated and qualified as required in line with site procedures
*Creation and updates of quality Raw Material Specification documents and other documentation as applicable to the Incoming Quality Control Laboratory
*Review of area specific SOPs to ensure all aspects of compliance are adhered to
*Perform environmental monitoring of Cleanroom environment
*Training of new Incoming Quality Control personnel when appropriate
*Participate in process/product/OOS investigations related to the Incoming Quality Control process as required
*Implementation of Corrective and Preventative actions related to Incoming Quality Control as required
*Support site quality activities, including but not limited to: Annual Product quality reviews, recall activities, change control etc.
*Ensure regular Quality interaction with other departments within GWWO and Grifols sister sites
*Participate in any regulatory, corporate or Internal audits as required
*Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
*Complete any process/product/system improvement projects as assigned in including method transfers
REQUIRED KNOWLEDGE, SKILLS AND QUALIFICATIONS:
*Excellent verbal and written communication skills.
*Fluent in both Spoken and Written English.
*Strong technical writing skills
*Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
*Competence in Microsoft packages specifically word, excel and PowerPoint
*Good organizational skills
*B.Sc. or equivalent in chemistry, biochemistry, pharmaceutical science or related field
*Minimum 2 years' experience in a quality or production function within the pharmaceutical industry
DESIRABLE KNOWLEDGE, SKILLS AND QUALIFICATIONS:
*Sampling and Testing of incoming raw materials in a cleanroom environment