Quality Assurance Manufacturing Monitoring Supervisor
Quality Assurance Manufacturing Monitoring 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 Analysts and to complete and support activities within the Quality Department relating to Environmental Monitoring, Personnel Qualification, Contamination Control and Clean Utility Sampling. To provide Quality support for the aseptic manufacturing operations in GWWO. To act as delegate for activates performed by QA Manufacturing Manager
- Work with Maintenance, Manufacturing, Quality Control and Validation Departments to ensure QA Manufacturing Monitoring activities are completed in compliance with all regulatory requirements and per schedule.
- Leadership and cross functional updates
- Notify relevant parties of issues and sampling status to ensure compliance maintained.
- Input and monitor QA Manufacturing Monitoring metrics and KPIs
- Responsible for all tasks and resources including cross functional co-ordination required to complete sampling activities within regulated environment in the required timeframe.
- QA Manufacturing Monitoring activities:
- Supervision of QA Manufacturing Analyst team to carry out tasks.
- SME for Environmental Monitoring and Aseptic Monitoring activities in Grade A, B, C and D areas and to provide on the job training for Qualification of team members.
- Oversight of all monitoring activities relating to Clean Utilities, Environmental Monitoring and Personnel Monitoring.
- Qualify in gowning and participate in Aseptic Process Simulation monitoring intervention for entry to Grade A area.
- Support the training
- Liaise with Equipment suppliers to source Monitoring equipment and ensure appropriate qualifications/ calibrations are completed in line with compendial and regulatory guidelines.
- Ensure QA Manufacturing monitoring procedures are created/reviewed in line with compendial and regulatory guidelines
- Participate in HACCP risk assessment for revision of Environmental Monitoring Sampling Plans.
- Ensure Inspection plans are up to date on SAP system.
- Schedule sampling activities including release of inspection lots.
- Completion of monitoring and sampling activities - ensure correct samples per inspection plan.
- Perform trending of Environmental monitoring results, prepare monthly report for and attend and participate at the environmental review committee.
- Carry out technical review on data as required and support annual product quality reviews
- Lead investigation of sampling activities where trends are identified, and alert/action limit are reached or OOS reported for samples taken.
- Responsible for follow up corrective actions identified through the Deviation system
- Participate in and responsible for QA Manufacturing Monitoring related CAPA's.
- Support the quality audit/inspection programmes
- Support the 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 Assurance Manufacturing Manager for QA Manufacturing Monitoring activities.
- Any additional activities as assigned by the QA Manufacturing Manager
- Team Responsibilities:
- Ensuring training and development of QA Manufacturing Analyst 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 Monitoring 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 QA Manufacturing Monitoring team adhere to safety standards to maintain a safe working environment
- Develop, improve and implement QA Manufacturing Monitoring 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.
- Minimum 5 years QA/QC experience
- Bachelor's degree in Microbiology, Biochemistry or closely related scientific field
- Supervisory Experience in quality environment.
- Knowledge of and proficiency in Aseptic Behaviors and sampling techniques for personnel and environmental sampling in 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.
- Experience in statistical analysis including use of Minitab an advantage
- General knowledge of pharmaceutical plasma-derivative company process, equipment and their microbiological control an advantage
- Experience leading and facilitating Quality Risk Management.