Samenvatting
- Bedrijf
- GSK
- Locatie
- Rixensart, Walloon-Brabant 8000
- Sectoren
- Biotechnologie/Farmaceutica
- Type job
- Voltijds
- Onbeperkte duur
- Opleidingsniveau
- Master na master
- Carrièreniveau
- Midcareer (geen manager)
- Referentiecode
- PCK343-159781
Quality Assurance GMP Supervisor - Industrialization Clinical Lots - 34146
Position Title: Quality Assurance GMP Supervisor - Industrialization Clinical Lots - 34146
Working Location: Belgium-Rixensart
Employment Status: Full-Time Regular
Required Experience: 3 years
Required Education: Master's Level Degree
Travel Required: 0%
Job Description:
GlaxoSmithKline Biologicals is one of the world's leading vaccine producer and the fastest growing business within the GSK group today. Headquartered in Rixensart & Wavre, Belgium, GSK Biologicals employs approximately 9,000 people worldwide, including over 6,000 in Belgium. GSK Biologicals’ global production network is in the midst of becoming the largest in the entire vaccines industry. 13 sites on three continents manufacture, formulate, fill, pack, check and deliver over a billion doses of about 30 different vaccines.
Job Purpose:
- Organize and take the responsibility for Quality Assurance in filling and formulation production related to non-commercial vaccines for Industrialization department.
- Assure the GMP release of the filling and formulation non-commercial batches in compliance with the Good Manufacturing Practices and regulatory requirements.
- Optimize and maintain the compliance level of the quality systems with regulatory, GSK Corporate and GSK Bio standards for filling and formulation production.
- Assure readiness for Health Authorities GMP Inspections.
Responsibilities:
GMP and GSK Quality System Compliance:
- Establish SOP’s for clinical lots quality standards in collaboration with Global Quality Assurance.
- Make sure that Master Batch records and Standard Operating Procedures has been completed and endorsed by the staff authorized to do so.
- Approve master production records, procedures for filling and formulation production, validation protocol and reports for filling and formulation production activities.
- Make sure that any deviations, changes in filling and formulation production, and filling and formulation production checklists have been authorized by the persons responsible in accordance with procedures.
- Lead and initiate continuous improvement within the areas of responsibilities
- Manage quality trend analysis.
- Make sure that internal audits (self-inspection) are performed.
- Assure internal audits level 2.
- Prepare and participate to regulatory inspections: assure inspection readiness for filling and formulation production activities.
- Make sure that commitments are followed up and implemented.
- Coach and manage the QA staff through effective performance with KPI’s as instrument
- Ensure implementation of GMP training program for filling and formulation production staffs.
- Ensure a consistent approach to the interpretation and implementation of GMP standards (production deviations, change control, self inspections, ...)
- Maintain his knowledge and experience up to date in the light of technical and scientific progress and changes in quality management
- Understand technical/production problems and evaluate potential impact on product quality. Ensure critical topics are adequately and timely escalated to higher management.
People Management:
- Manage, coach, develop and motivate employees towards the pursuit of operational excellence and attainment of Good Manufacturing Practices.
- Provide leadership for change initiatives involving processes and people, which contribute to the overall effectiveness of the department.
- Provide leadership for the implementation of the OE culture.
Continuous Improvement / Organisation:
- Establish communication processes within the QA and operational units to enable flexibility and responsiveness in achieving customer satisfaction.
- Establish and implement organisation development plans to ensure fulfilment of projects objectives.
- Realize with the other members of the Industrialization Management team the project objectives.
Reporting:
- Compile and issue a monthly report to the intention of senior management.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.
Thank you for taking the time and effort to apply for this role. Please note that we will only contact you again if you are invited to interview. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish.
GSK is an equal opportunity employer.
Essential Skills:
- Strong knowledge in Quality Assurance
- Complete familiarity with current Good Manufacturing Practices.
- Knowledge in vaccines manufacturing and aseptic processes.
- Capacity to manage people.
- Good technical writing and teaching skills.
- Ensure a consistent approach to the interpretation and implementation of GMP standards.
- Solid problem solving and negotiation skills.
- Ability to evaluate compliance risk.
- Ability to build relationship with other departments (suppliers, customers)
- Set priority for team members to meet daily deadlines and coordinates work flow and work quality.
.
