Incoming Quality Control Lab Assistant Manager

Incoming Quality Control (IQC) Laboratory Assistant Manager is required for a 15-month maternity leave contract. The Incoming Quality Control Laboratory is responsible for the sampling, testing and release of packaging material for the Secondary Packaging facility and raw materials for current packaging plant and 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 Quality Control (QC) Manager of GWWO, the IQC Assistant Manager will act as delegate for all activities performed by the Quality Control Manager for Incoming QC activities in GWWO.
 

KEY RESPONSIBILITIES:

*Management of Incoming Quality Control Laboratory team
*Ensure correct sampling of raw materials/packaging materials in non-classified and cleanroom environment as required
*Ensure testing of raw materials/packaging materials is performed as per procedures and as required per the production plan
*Release of raw materials/packaging material
*Oversight of environmental monitoring of Cleanroom environment and management of any associated deviations
*Oversight of cleaning activities for the Incoming Quality Control sampling cabin and liaison with the contractor responsible for cleaning activities
*Ensure all Laboratory equipment is maintained, calibrated and qualified as required in line with site procedures
*Completion of quality Raw Material Specification documents and Quality review of other GWWO documentation as applicable
*Creation, review and update of area specific SOPs to ensure all aspects of compliance are adhered to
*Development of Incoming Quality control in line with the new albumin site requirements
*Represent the Incoming Quality Control department in any regulatory, corporate or Internal audits as required
*Training of new Incoming Quality Control personnel when appropriate
*Drive and oversee process/product/OOS investigations related to the Incoming Quality Control process
*Responsible for the implementation of Corrective and Preventative actions related to Incoming Quality Control
*Maintain, monitor and report Incoming Quality Control metrics and KPIs to ensure material is available to internal
*Ensure regular Quality interaction with other departments within GWWO and Grifols sister sites
*Support site quality activities, including but not limited to: Annual Product quality reviews, recall activities, change control etc.
*Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
*Support any projects impacting the Incoming Quality Control department such as Method Transfers, Process Improvement or Harmonization projects
*Act as a delegate for activities performed by the Quality Control Manager for Incoming Quality Control activities
 

REQUIRED KNOWLEDGE, SKILLS AND QUALIFICATIONS:

*Excellent verbal and written communication skills. Must be able to read, write and speak English
*Strong technical writing skills
*Strong interpersonal skills with the abilty to interact with all levels of personnel in a professional manner
*Ability to handle multiple projects and deadlines
*Demonstrated problem solving skills
*Demonstrated project management skills
*Strong Decision-Making skills
*Method Transfer and qualification knowledge
*Equipment Qualification Experience
*Competence in Microsoft packages; specifically, Word, Excel and Powerpoint
*BSC or equivalent in chemistry, biochemistry, pharmaceutical science or related field
*Minimum 1 year supervisory/management experience in a quality or manufacturing setting
*5 years progressive experience as an individual contribution in a GMP laboratory Environment
 

DESIRABLE KNOWLEDGE, SKILLS AND QUALIFICATIONS:

*Sampling and Testing of incoming raw materials in a cleanroom environment
*SAP experience
*M.Sc. qualification