QC Microbiology Supervisor (Maternity Cover)

Location: 

Dublin, IE

Contract Type:  Temporary Full-Time
Area:  Quality
Req Id:  460429

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.

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) 

 

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