Specialist QA Release, Trending

**_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

**_ Specialist QA Release, Trending & Compliance for HAV _**:
Are you looking for a QA release role for the Belgian manufacturing site? Would you like to join a motivated manufacturing unit to ensure release of batches and continuous improvements to our processes?

You will raise and maintain the status of quality in the organization and enables a company to promote itself as one that provides quality goods and services. You will be involved in the Total Quality Management (TQM) programs and the development of standard procedures in accordance with GSK standards and cGMP Regulations.

**In this role you will **

Interact with multiple stakeholder such as manufacturing teams, regulatory affairs, supply teams, Quality control coordinator, inspection teams and GSK colleagues from other sites.

**Main responsabilities of the role are **

Raises and maintains the status of quality in the organization
- Release _
- Drive and lead the release process for the area of responsibility for bulk and media
- Ensure the release of products in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements.
- Manage technical / release problems, evaluate potential impact on product quality and ensure timely escalation of issues
- Trending _
- Perform trend analysis on different quality systems to support QA Operations to further improve the systems and results
- Compliance _
- Prepare, Coordinate, lead Quality meeting (Inspection Readiness, Quality Council...)
- Ensures timely escalation of quality issues, manages and reviews deviations, complaints, change controls in a timely manner.
- Drive and build the self-audits plan and Quality oversight, coach newcomers as per LSPOC
- Perform the QA oversight linked to QA RTC activities (i.e. Write off, learning)
- Act as key spoke person during regulatory inspection and internal audits, drive the audit preparation plan
- Act as a local single point of contact (LSPOC) for QMS (Quality Management System), ensure all requirements of the standards are cascaded in SOP’s, accountable for gap analysis and related action plans
- 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.
- Approve MPU master data modifications.

**_ This job opportunity is a permanent contract _**_not_**_ opened for relocation._**

**_ Why you? _**

Qualifications & Skills:

- University degree in sciences: Pharmacist, Bio Engineer, Biologist, Chemist
- Good knowledge of cGMP
- At least 5 years professional experience from which at least 3 years in a GMP Environment related to pharmaceutical production with preference to aseptic; Experience in production operation is appreciated
- Fluent in spoken and written English and French, including presenting and negotiating
- Expertise in Quality environment.

Preferred Qualifications & Skills:

- Good organizational skills, effective time management, ability to manage multiple tasks
- Ability to negotiate and influence stakeholders
- Ability to coach the stakeholders
- Important proactivity
- Ability to promote teamwork
- Li-GSK

GSKTechTalent

**_ Why GSK?_**:_ _**

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

**GSK Vaccines** - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

**Our department**:_ _**

**The QA Belgium departments** manage all product quality related activities in industrial operations in Belgium, including regulator