Incoming Quality Control (IQC) Manager

Incoming Quality Control (IQC) Manager

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.

Incoming Quality Control (IQC) Manager is required for the Incoming Quality Control Laboratory responsible for 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.

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.

What your responsibilities will be

Communication:

• Daily briefing on Incoming inspections review and approval
• Notify relevant parties of issues and testing status to ensure any threat to supply of product is escalated.
• Provide quality performance information as required
• Input and monitor Incoming Quality metrics and KPIs to ensure material is available to internal/external customers when needed
• Ensure regular Quality interaction with other Departments
• Responsible for all tasks and resources including cross functional co-ordination required to complete relevant IQC activities within regulated environment in the required timeframe

IQC Release Activities:

• Oversight of all activities relating to IQC release activities
• Sampling of packaging and raw materials
• Release of all packaging materials and raw materials
• Oversight of all activities related to Incoming Lab calibration
• Managing of IQC team to release material
• Ensure correct sampling (clean area classification, methods, gowning etc.) of relevant albumin process related materials inside GMP compliant sampling cabin
• Oversight of all testing of secondary packaging and raw materials
• Completion of Quality RMS documents
• Carry out technical reviewed on data as required and support annual product quality reviews
• Support the quality audit/inspection programmes
• Support product recall activities
• Support the process change control system
• Drive and oversee process/product/OOS investigations (including planned / unplanned deviation)
• Responsible for follow up corrective actions identified through the Deviation system.
• Support any projects that impact IQC
• Act as delegate for all activities performed by the Quality Control Manager for IQC activities

Team Responsibilities:

• Ensure training and development of IQC team members in conjunction with team development, team goals and business needs.
• Responsible for team success by agreeing, implementing and monitoring individual and team objectives and targets to ensure IQC tasks are completed whilst ensuring company policies and procedures are adhered to.
• Responsible for hiring new colleagues if system/schedule requirements drive demand.
• Setting goals and objectives for and to provide feedback to QC team members.
• Responsible for team safety.
• Review of area specific SOPs and ensure all aspects of compliance are adhered to.
• GMP implementation and site-wide Quality Awareness.
• Liaise with other Department representatives to promote improvements in GMP and Quality standards.
• Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.
• Support any projects that impact IQC
• Act as delegate for all activities performed by the Quality Control Manager for IQC activities

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Competence in Microsoft packages specifically word, excel and PowerPoint and in SAP
• Strong Technical Writing ability
• Ability to handle multiple projects and deadlines
• Proficiency in communicating and collaborating at all organisation levels.
• Problem Solving: Identifying problems, recognizing significant information, gathering and coordinating relevant data; diagnosing possible causes
• Project management skills
• Strong Decision-Making skills
• 5 years progressive experience as an individual contributor
• B.Sc. or equivalent in chemistry, biochemistry, pharmaceutical science, or related field.

Desirable knowledge and Skills

• Supervisory/Management experience in a quality or manufacturing setting
• M.Sc. Qualification
• Lead Auditor Certified

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!

• We look forward to receiving your application!
• Grifols is an equal opportunity employer.
• 40 hours per week Mon-Fri
• Contract of Employment: Permanent