Microbiology Supervisor

Recruiter
Grifols
Location
Dublin West, Dublin
Salary
bonus, health insurance , 25 days hols
Posted
14 Jul 2021
Closes
11 Aug 2021
Ref
QC Micro
Contact
Ann Marie Corcoran
Sector
Scientific
Job Type
Permanent
Hours
Full-time

QC Microbiology Supervisor is required for a new 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 Manager for QC Microbiology activities in Grifols Worldwide Operations Ltd (GWWO).

 

 

 

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.

 

 

 

 

 

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