Sterility Assurance Manager
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Mar
QA Sterility Assurance Manager:
In this role you will:
Sterility Assurance:
- Key contact for the organization for all matters related to Sterility Assurance including Aseptic Practices, Environmental monitoring, for clean rooms (viable and nonviable) operators and critical utilities, Surface Cleaning and Sanitization, Sterilization, Media Fill and
Sterility Failures:
provides expert, support to production and QA.
- Build a strong network with GSK Organization for knowledge and best practice sharing
- Approves scientific and technical reports (test procedure, validation report, scientific report, deviations reports)
- Puts in place and leads specific task forces to solve technical issues in close collaboration with the shared service sterility assurance
- Guarantees the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method validation)
- Assures the adequate treatment of all EM deviations with QA, Operations and CMO involved
- Ensures and supports the implementation of adequate training for aseptic practices and sterility assurance, including shop floor mentoring as required
- Support the CMO on continuous improvement plan related to Sterility Assurance
Quality / Regulatory / EHS:
- Ensures compliance to local and international standards (e.g. Annex 1), cCMP, Regulatory requirements and all GSK Quality Management Systems (QMS) policies and procedures as applicable as well as adherence to the Environmental, Health and Safety rules.
- Act as SME (Subject Matter Expert) within External Manufacturing Organization for Quality Systems (Deviation, CAPA)
- Chair and coordinate the Quality Governance meeting within Quality EM-V team that may evolve from time to time (e
g:
Deviation CAPA Review Board,); Issue minutes on a timely manner, comply with write right principles and ensure appropriate escalation
- Depending on business need, support QSPOC for Quality operational activities
_ This job opportunity is a permanent contract __not_
_ opened for relocation. _
_Why you? _
Qualifications & Skills:
- University Scientific background (Pharmacist, PhD in life sciences, Bio Engineer,.)
- 510 years professional experience in the pharmaceutical / biotech /medical device / food industry or equivalent environment. Including at least 3 years of proven aseptic manufacturing and microbiology experience
- Direct experience with GxP regulated environment within a major jurisdiction
- Proven experience in Quality Assurance, not necessarily within a quality department
- A strong knowledge of technology, product, processes is required to obtain the right level of influence, credibility and decision making
- Good knowledge of GMP's, regulatory requirements and standards
Qualifications & Skills:
- Good Interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and welldeveloped relation building skills to gain trust and credibility and to build a great place to work and good social climate within the team
- Very good knowledge of cGMP for biological products
- Good knowledge of FDA/EU/ICH/WHO guidelines and inspections
- Strong analytical and problem solving (trouble shooting) skills and flexible thinking capability
- Continuous improvement focus ability to challenge the status quo
- Effective communication skills, good level of written and spoken French and English
- Effective influencing skills ability to influence at all levels of management
- Training and mentoring skills
- Strong quality and results oriented mindset
- Li-GSK
_ Why GSK?_:
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people.While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Find out more:
Annual Report 2021
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
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