Specialist QA for Qc

il y a 6 jours

Wavre, Belgique GSK Temps plein

**_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 for QC - analytical methods - CDD_**:**Job purpose**
- Provide QA support to QC Analytical Strategy & Technology Innovation - QC AS&TI (Analytical Method validation, analytical methods life cycle and new technology introduction);
- Assure the follow-up of validation, transfer and life cycle of new analytical methods introduced in QC department in compliance with the good manufacturing practices and regulatory requirements.
- Ensure regulatory inspection readiness
- Provide QA expertise;
- Act as back up of the QA Manager of the QC AS&TI department
**In this role you will**:

- Approve the validation documentation regarding the GMP requirements and the GSK Vaccines procedures for analytical method validation protocols and reports, analytical method transfer protocols and reports (R&D to QC, intra QC), analytical method periodic assessment (RVA) in different fields: Biochemistry, Biology, Biology molecular, Physico chemistry and virology.
- Approve the qualification documentation regarding the GMP requirements and the GSK Vaccines procedures for Reagents and Standards qualification protocols and reports.
- Review and approve documentation related to the Reagents and Standard management: Instruction for use and lifetime documentation.
Ensure compliance of the operations with cGMP, Authorities and QMS requirements and escalate major quality issues and/or compliance gaps to management and relevant governing bodies in AS&TI (Analytical Strategy & Technology Innovation) QC department
- Ensure the compliance on EHS topics and develop the EHS mindset within peers;
- Actively practice escalation and cascade of information through Tier Meetings;
- Ensure the inspection readiness status for L3/L4 audits;
- Escalate major risks and L1 deviation(s) to his manager;
- Approve deviation L2-L3 (and manage L1 by delegation of its manager) and related CAPA in accordance with procedures and timelines;
- Ensure the implementation and the compliance of CA/PA;
- Approve QC AS&TI eCC (change control) in accordance with procedures and timelines;
- Approve analytical procedures (eSOP³) in accordance with procedures and timelines;
- Ensure and contribute to QA on the floor program in QC AS&TI department;
- Supervise / Manage day to day QA activities in his/her area of responsibility and ensure the relevant QA Oversight is in place
- Manage complex technical problems, evaluate potential impact on product quality and escalate to management
- Promote continuous improvement mindset in a day to day activities.

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

**_
Why you?
- **

Qualifications & Skills:

- Bioengineer/Pharmacist or equivalent
- 2-5 years' experience in pharmaceutical environment
- Experience in FDA/EU/WHO inspection
- Good knowledge of FDA/EU/ICH/CDN/AUS guidelines
- Good knowledge of Quality control laboratory process (method validation included);
- Experience in biologicals manufacturing/testing processes

Preferred Qualifications & Skills:

- Good communication skills
- Good knowledge of English (written and spoken).
- 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**:
Global Industrial Operations (GIO):
Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter

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