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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We're excited to invite you to lead our Quality Control (QC) Chemistry Laboratory team in our purification and aseptic filling facility at Grifols Worldwide Operations (GWWO). As
QC Chemistry Manager
, you will play a key role in ensuring high-quality laboratory testing of clean utility, raw material, in-process and final container materials, maintaining full compliance with current Good Manufacturing Practices (cGMP) and safety standards.
Key Responsibilities
* Management of the QC Chemistry team to carry out required chemistry, immunochemistry and protein testing as required
* Ensure QC testing of clean utility, raw material, in-process and final container testing is performed as per the production plan
* Manage integrity of Laboratory Data
* Ensure all methods are qualified/validated in line with site procedures and regulatory/compendial requirements
* Ensure all equipment is validated, maintained, calibrated, and requalified in line with site procedures and regulatory/compendial requirements
* Creation, review and update of test methods and SOPs to ensure all aspects of compliance are adhered to
* Drive and oversee process/product/OOS/deviation investigations
* Implementation of Corrective and Preventative Actions
* Maintain, monitor and report QC Chemistry metrics and KPIs
* Ensure training and development of QC Chemistry team members in conjunction with team development and goals via the performance management process
* Represent QC Chemistry in any regulatory, corporate or internal audits
* 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 (APQRs), recall activities, change control etc.
* Responsible for any projects impacting QC Chemistry such as Method Transfers, Process Improvement or Harmonisation Projects
* Keep Abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
* Manage the safety and performance of QC Chemistry in line with safety regulations and site procedures
* Perform additional duties as assigned
* Act as a delegate for activities performed by the QC Senior Manager for QC Chemistry activities
Knowledge & Skills
* Full understanding of relevant cGMP, quality and compliance regulations
* Experience with chromatography instrumentation and methods
* Experience with protein chemistry instrumentation and methods
* Method Transfer and qualification experience
* Understanding of pharmacopoeial requirements and methods
* Excellent communication skills at organisation, team and individual levels
* Demonstrated problem solving skills
* Strong decision making skills
* Strong presentation skills
* Ability to manage multiple projects to plan/budget
* Experience in developing analytical methods is desirable
* Experience with Statistical Process Control (SPC) is desirable
* Experience with Lab Management Systems & SAP is desirable
Qualifications
* BSc or equivalent in chemistry, biochemistry, pharmaceutical science or related field
* Minimum 3 years supervisory/management experience
* 8 years progressive experience as an individual contributor in a fast paced GMP Laboratory environment
* M.Sc. qualification is desirable but not essential
Our Benefits Include
* Highly competitive salary
* Group pension scheme - Contribution rates up to 7%
* Private Medical Insurance for the employee
* Ongoing opportunities for career development in a rapidly expanding work environment
* Succession planning and internal promotions
* Education allowance
* Wellness activities - Social activities eg. Golf, Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you.
Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3
Learn more about Grifols