Quality Assurance Manufacturing Supervisor is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).
This role offers a chance to work in a state of the art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus.
Reporting directly to the QA Manufacturing Manager of GWWO. The position will be responsible for a team of QA Manufacturing Specialists and to complete quality activities such as review and approvals within the Quality Department and to provide Quality support for the aseptic manufacturing operations in GWWO. To act as delegate for activities performed by QA Manufacturing Manager
Daily briefing on Quality review/approval status.
Leadership and Cross Functional updates - Provide quality performance information and update monthly at steering committees as required.
Ensure regular Quality interaction with other Departments including Validation, Manufacturing, Quality Control and Maintenance.
Interact with sister sites for technical transfer activities and as part of working groups for harmonisation activities
QA Manufacturing activities:
Supervision of QA Manufacturing Specialist team to carry out tasks.
Oversight of QA Activities for Manufacturing Site including, qualification pack review, batch review, deviation impact assessment, change control impact assessment, investigation oversight and CAPA implementation.
Establish KPIs for the QA Manufacturing Group
Support the Aseptic Process Simulation and Batch Manufacture activities including observation of aseptic activities and interventions as required.
Qualify in gowning for entry to Grade A area.
Review and approval of QA procedures for Manufacturing plant ensuring compliance with compendial, data integrity, Annex 1 and regulatory guidelines.
Support deviation investigations including execution as SAP co-ordinator of deviations, document QA impact assessment and approval of CAPA plans.
Participate and lead risk assessments to support contamination control strategy and ensure compliance with Annex 1.
Batch review - results recording and usage decision on SAP. Ensure Inspection plans are up to date on SAP system.
Provide Quality support for aseptic manufacturing operations and GMP implementation at GWWO.
Oversight of Albumin Manufacturing Processes to ensure a state of compliance and ensure audit readiness for the manufacturing facility.
Perform Walkthrough Audits of the facility.
Participate in the self-inspection Programme
Support continuous improvement projects such as implementation of electronic batch review.
Generation of annual product quality reviews
Flexibility and willingness to carry out shift work.
Act as delegate for all activities performed by the Quality Assurance Manufacturing Manager.
Any additional activities as assigned by the QA Manufacturing Manager
Ensuring training and development of QA Manufacturing Specialist 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 QA Manufacturing 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
Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and deliver training to the QA team in these.
- Minimum 5 years QA/QC experience
- Bachelor's degree in Microbiology, Biochemistry or closely related scientific field.
- Knowledge of and proficiency in Aseptic Behaviors for personnel a Grade A area.
- 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.
- Supervisory Experience in quality environment.
- Experience in statistical analysis including use of Minitab.
- General knowledge of pharmaceutical plasma-derivative company process, equipment and their microbiological control.
- Experience leading and facilitating Quality Risk Management.