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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 **** 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.
Position Summary
QC Microbiology Manager is required for a purification and aseptic manufacturing plant for the blood protein albumin at Grifols Worldwide Operations (GWWO)
To complete and support QC microbiology activities in a timely manner ensuring GMP Compliance.
To act as delegate for all activities performed by the Quality Control Senior Manager for QC Microbiology activities in Grifols Worldwide Operations Ltd (GWWO).
Key Responsibilities
Communication:
Work with QC chemistry and Incoming QC teams to ensure QC department tasks completed and goals achieved
Participate in international project teams relating to QC and wider quality activities where travel may be required
Leadership and cross functional updates
Notify relevant parties of issues and microbiology testing status to ensure any threat to testing is escalated.
Provide quality performance information as required
Input and monitor QC Microbiology metrics and KPIs
Ensure regular Quality interaction with other Departments
Responsible for all tasks and resources including cross functional co-ordination required to complete relevant QC microbiology activities within regulated environment in the required timeframe
QC Microbiology Laboratory Activities:
Management of QC Microbiology team to carry out tasks
SME for QC microbiology test methods and provide hands-on guidance and training when needed
Oversight of all activities relating to QC microbiology
Liaise with Equipment suppliers to source QC Equipment and computerised Systems and ensure appropriate qualifications/ calibrations are completed in line with compendial and regulatory guidelines
Ensure QC equipment and services maintained in an operational (and safe) state
Ensure QC procedures are created/reviewed and verified/validated where required in line with compendial and regulatory guidelines
Completion of microbiology test methods
Ensure correct testing (EM, Water, Raw materials, In-process and Finished product) of relevant albumin process related materials carried out by QC microbiology analysts
Review and Release of QC microbiology test results
Carry out technical review on data as required and support annual product quality reviews
Drive and oversee process/product/OOS/OOT investigations (including planned / unplanned deviation)
Responsible for follow up corrective actions identified through the Deviation system
Participate in and responsible for QC related CAPA's.
Support the quality audit/inspection programmes
Support the process change control system
Support projects and continuous improvement initiatives within the Quality department and other functional areas
Flexibility and willingness to carry out shift work when required
Act as delegate for all activities performed by the Quality Control Senior Manager for QC microbiology activities
Team Responsibilities:
Ensuring training and development of QC microbiology 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 QC microbiology tasks are completed whilst ensuring company policies and procedures are adhered to
Provide feedback to team members to facilitate development
Hiring new colleagues if system/schedule requirements drive demand
Ensure the QC microbiology team adhere to safety standards to maintain a safe working environment
Develop, improve and implement QC procedures, processes and systems
GMP implementation and site-wide Quality Awareness
Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training.
Ensure QC microbiology team aware
Act as delegate for all activities performed by the Quality Control Senior Manager for QC microbiology activities
Knowledge & Skills:
Knowledge of and proficiency in a wide array of current microbiological techniques and instruments including troubleshooting skills.
Strong ability to review analytical data, analyse details and perform structured decision-making on a daily basis.
Experience with investigating and determining root cause of Out of Specification/Out of Trend events and writing thorough reports.
Problem Solving: Identifying problems, recognizing significant information, gathering and coordinating relevant data; diagnosing possible causes
Strong technical writing skills.
Excellent verbal and written communication.
Must be able to read, write, and speak English.
Competence in Microsoft packages specifically word, excel and PowerPoint and in SAP
Project Management Skills with ability to handle multiple projects and deadlines
Proficiency in communicating and collaborating at all organisation levels.
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
Strong Decision-Making skills
Interpret and apply applicable regulatory guidelines.
Minimum 5 years QC experience
Management/Supervisory Experience in quality environment
Experience in method transfer and verification/validation desirable
Experience in statistical analysis including use of Minitab desirable
General knowledge of pharmaceutical plasma-derivative company process, equipment and their microbiological control desirable
Strong knowledge of analytical techniques for biologics or protein-based therapeutics desirable
Qualifications:
Bachelor's degree in Microbiology, Biochemistry or closely related scientific field
Requires a minimum of 5 years of QC microbiology experience
Our Benefits Include:
Highly competitive salary
Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
Private Medical Insurance for the employee
Ongoing opportunities for career development in a rapidly expanding work environment
Succession planning and internal promotions
Wellness activities - Social activities eg.
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
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