QC Microbiology Supervisor (Maternity Cover)
Dublin, IE
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Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions. |
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QC Microbiology Supervisor Maternity Leave Contract
12-month maternity contract position is required for the Albumin protein purification and aseptic manufacturing plant 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 Manager for QC Microbiology activities
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 maybe 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:
Supervision 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 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 Manager for QC microbiology activities
REQUIREMENTS
Knowledge of and proficiency in a wide array of current microbiological techniques and instruments including troubleshooting skills.
Strong ability to review analytical data, analyze 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
Bachelor’s degree in Microbiology, Biochemistry or closely related scientific field.
Requires a minimum of 2 years of QC microbiology experience.
Supervisory Experience in quality environment.
Experience in method transfer and verification/validation.
Experience in statistical analysis including use of Minitab.
General knowledge of pharmaceutical plasma-derivative company process,
equipment and their microbiological control.
Strong knowledge of analytical techniques for biologics or protein-based therapeutics.
Location: EMEA : Ireland : Dublin || EMEA : Czech Republic : Praha || EMEA : Egypt : Egypt || EMEA : France : Meyreuil || EMEA : France : Paris || EMEA : Germany : Augsburg || EMEA : Germany : Bayreuth || EMEA : Germany : Berlin-Charlottenburg || EMEA : Germany : Berlin-Hellersdorf || EMEA : Germany : Berlin-Marzahn || EMEA : Germany : Berlin-Prenzlauer-Berg || EMEA : Germany : Berlin-Tegel || EMEA : Germany : Berlin-Wedding || EMEA : Germany : Bonn || EMEA : Germany : Brandenburg a. d. Havel || EMEA : Germany : Chemnitz || EMEA : Germany : Dortmund || EMEA : Germany : Dresden-Fetscherplatz || EMEA : Germany : Dresden-Kaditz || EMEA : Germany : Dresden-World Trade Center || EMEA : Germany : Erfurt || EMEA : Germany : Essen || EMEA : Germany : Frankfurt (Oder) || EMEA : Germany : Frankfurt am Main, Niederrad || EMEA : Germany : Freiberg || EMEA : Germany : Fürth || EMEA : Germany : Gera || EMEA : Germany : Gotha || EMEA : Germany : Grimma || EMEA : Germany : Görlitz || EMEA : Germany : Halle (Saale) || EMEA : Germany : Hamm || EMEA : Germany : Ingolstadt || EMEA : Germany : Jena || EMEA : Germany : Langen-Hessen || EMEA : Germany : Leipzig Zentrum Südost || EMEA : Germany : Leipzig-Connewitz || EMEA : Germany : Leipzig-Gohlis || EMEA : Germany : Leipzig-Markt || EMEA : Germany : Lübeck || EMEA : Germany : München || EMEA : Germany : Nürnberg || EMEA : Germany : Plauen || EMEA : Germany : Potsdam || EMEA : Germany : Regensburg || EMEA : Germany : Rostock || EMEA : Germany : Schwerin || EMEA : Germany : Weimar || EMEA : Germany : Zwickau || EMEA : Hungary : Budapest || EMEA : Hungary : Debrecen || EMEA : Hungary : Miskolc || EMEA : Hungary : Nagykanizsa || EMEA : Hungary : Pecs || EMEA : Italy : Milán || EMEA : Italy : Siena || EMEA : Italy : Vicopisano (Pisa) || EMEA : Poland : Warsaw || EMEA : Portugal : Rio de Mouro || EMEA : Slovakia : Bratislava || EMEA : Sweden : Stockholm || EMEA : Switzerland : Allschwil || EMEA : Switzerland : Düdingen || EMEA : United Arab Emirates : Dubai || EMEA : United Kingdom : Cambridge:Grange Castle (Dublin)