Senior Specialist QA Rtc
il y a 1 semaine
**_Be You’ at GSK
- **
At GSK, we're a company with a purpose to **help people do more, feel better and live longer. **We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.
We will be delighted to hear from talented individuals that align to **our values. These **are at the heart of everything we do and include**:Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.**
**When you set out on your adventure at GSK, we make a deal. **You commit to living our values and expectations and performing against our **Innovation, Performance and Trust **priorities. In return, GSK commits to providing the **right environment for you to thrive. **Together, we build an environment where we can all thrive and focus on what matters most to each of us.
As a, we empower you to be yourself, share ideas and work collaboratively
**_
QA RTC Manager_**
**_
Job purpose:_**:
- **
Act with colleagues of the MPU Quality Assurance team and QA release team to ensure the continuous supply of vaccines in line with GSK business objectives to meet customer needs.**:
- Drive and lead the release QA release process in the MPU to ensure a continuous and effective release of commercial batches (intermediate or finished products produced within the Manufacturing Performance Unit) in compliance with Good Manufacturing Practices and Regulatory requirements.
- Analyze quality performance and provides trending
Be responsible for the leadership of the QA release, trending and compliance team within the MPU.
- Represent QA in meetings related to the area of responsibility and participate to MPU Quality Council
**In this role you will be in charge of the following activities**:
- Release- Assure the QA release of batches at each production step in compliance with GMP requirements including documentation and certificate review
- Manage technical / release problems, evaluate potential impact on product quality and ensure timely escalation of issues
- Assure the management of complaints and assure the management of product recalls? (Primary contact for any release related issues for GSK clients including health authorities (EMEA, FDA, AFFSAPS, PEI, SWISS MEDIC, ISP, MoHs..) and non-profit organizations (WHO, UNICEF )
- Ensure inter-MPU **back up** in the area of responsibility as required
- Trending- Perform trend analysis on different quality systems to support QA Operations to further improve the systems and results
- Contribute to Inter MPU meetings to share and review trending results as to foster continuous improvement and manage risks
- Contribute to the quality strategy and the preparation of the Quality Plan for the MPU, prepare dashboards to communicate performance against objectives
- Compliance- Ensure compliance of MPU processes with cCMP's and GSK Vaccines Belgium Quality Management System
- Ensure Documentation Management within the MPU is aligned with GSK Vaccines Belgium Documentation system / SOPs and performs compliance check as well as alignment with method of production, process validation and regulatory files prior to procedure approval ; ensures all MPU master production documentation is in line with validation and regulatory files prior to QA Operation approval
- Approve MPU specific GMP training packages for QA, Production and support staff within the MPU and ensures QA staff are adequately trained/certified and coach QA team through presence on the shop floor
- Approve MPU static master data
- Approve specific MPU compliance and quality risks and follows up risk register actions Timely escalates critical non-compliance and compliance/quality risks within the MPU to management and manages these risks through the risk register process
- Ensure MPU files and Core files are aligned with current MPU processes and regulatory requirements
- Ensure all changes implemented within the MPU are aligned with GSK Vaccines Belgium change control procedures and regulatory requirements (MPU change control approvals)
Prepare internal L2 audit and L1 self-inspection programs for the MPU and ensure they are performed according to schedule
- Organize and take the Quality Assurance responsibility for new projects (facilities - utilities - equipment - processes) in the MPU
- Ensure MPU regulatory files are adequately reviewed before submission
- Drive a continuous Quality and Compliance mindset within the MPU to ensure compliance with cGMP’s and GSK Quality Management Systems as well as Regulatory Intelligence
- Maintain knowledge and experience up to date in the light of technical and scientific progress and changes in quality management
- People Management & Development- Lead, select, train, evaluate, coach and motivate team towards the pursuit of excellence and attainment of Good Manufacturing Practices
- Ensure optimal staffing levels and c
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