Qualified Person

Basic qualifications: 

What qualifications do I need to apply?
You will hold a degree or equivalent level in a scientific discipline in the area of quality and / or batch certification.

You will be a fully qualified QP within the EU

You will be a member of a professional body e.g. RSC, RPSGB, SoB

As the QP you will be named on the site Manufacturing Authorisation

Eligibility:
You must be eligible to work in the UK without sponsorship to be considered for this role.

Preferred qualifications: 

What else would benefit me in this role?
If you are Eligible / Performed as Qualified Person.

If you have experience within primary pharmaceutical manufacture.

If you have a good understanding of regulatory requirements and the principles that govern the operation and inspection of primary pharmaceutical manufacture

Why is this level preferred in this role?
A qualified person status provides an educational standard to become a fully rounded quality professional. The Ulverston site manufactures sterile API's, oral API's and intermediates and these require specialized knowledge to support control and release.

Details: 

About GSK Ulverston Site
Our Ulverston site is situated close to the beautiful English Lake District in the South Lakeland district of Cumbria in North West England. The site has been operational since 1948 and remains an important part of the local community with the key products being Zinacef, Fortum and Zinnat, due to the continued success of the site there is a major redevelopment of the sterile facility planned in 2017 that will see the installation of a brand new state of the art facility, with further plans for a bio-pharm facility to be confirmed in the near future.

What is the purpose of the QP role?
As the QP you will lead a team of Operation Quality staff supporting the site antibiotic manufacture.

You will be have legal responsibility for QP batch release and will be named on the site’s Manufacturing Authorization. They will be active in providing a compliant and efficient service for the certification and release of batches, potentially including sterile batches, in accordance with EU, U.S. and other global GMP requirements.

You will work within the Quality Unit with alignment to a specific Operational Value Stream, the QP may also be responsible for managing a team of QA batch reviewers. 

As the QP you will provide technical expertise to support improvement activities and resolve quality issues.

What are the key responsibilities?
Management of a team of professional OQ staff.

To uphold the professional responsibilities arising from being a QP named on the site Manufacturing Authorisation.

Assuring the safety, quality and efficacy of intermediate and API batches released from site.

Liaising with other Quality Unit groups to ensure that all other aspects of testing and validation have been completed before batch release.

To maintain a compliant and efficient service for the release of manufactured batches.

To ensure that documentation standards are met within the manufacturing areas.

To resolve issues related to any unplanned changes/deviations that may occur during manufacture.

To support key Quality system process across the site including investigations, deviations, root-cause analysis workshops and verification of CAPA.

Support Level 2 audit schedule as an auditor or through CAPA development/ verification.

Support the Level 3 & 4 CAPA verification process.

What are the pay & benefits?
PAY - We will reward your contributions to GSKs success through your salary, bonus or sales incentives, and recognition awards. 

Competitive Base Salary – Your salary is paid monthly on the 20th day of the month (or nearest business day) It is reviewed each year to ensure it stays competitive and reflects your performance and contribution to GSK’s strategy.

CAR ALLOWANCE – £5,544 per annum, paid in equal monthly instalments

12% Annual Target Bonus – You individual performance is worth 60% if your total bonus and is based on the achievement of your personal objectives. The high level results of your business area is worth 40% of your total bonus.

SHARES & SAVINGS – Gives you a stake in GSK’s success and helps you save for the future, in partnership with GSK.

Share Reward – Share reward allows you to invest up to 5% (maximum of £125)of your salary each month in GSK shares and receive a free share for every share you buy.

Share Save – Share Save is designed to help you save for the medium term, by giving you the opportunity to buy discounted GSK shares at the end of a three year savings period.

GSK Pension Plan – You automatically become a member of the GSK pension plan when you join GSK. An account is opened in your name and GSK contributes a core amount of 7% of your pensionable salary into your account each month. You are also required to make a contribution of 2%, GSK will match any contributions you make up to a maximum of 3% of your pensionable salary (total contributions upto 15%)

HEALTH & LIFE – Looks after you and your family’s health & wellbeing. 

Holidays – You are entitled to 26-days paid personal holiday each year (increasing to 27 days after 5yrs and 28days after 10yrs service) plus eight paid public holidays.

Healthcare Plan – The GSK Healthcare Plan is designed to you and covered family members access to prompt medical treatment. You can join the healthcare plan at anytime. 

Health MOT – You will be invited to have a Health MOT once every 2 years. The health MOT is a free and confidential health check.

Tax Free: Plans including bikes, health assessments, holiday and childcare

DEVELOPMENT – Our Performance Development Plan (PDP) is designed to drive business performance and growth over time, and support your development by making it clear what is expected of you so you can have a rewarding career at GSK.

How do I apply?
Closing date for applications: Friday 28 October 2016

When applying for this role, please ensure you use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. 

The information that you have provided in your cover letter will be used to assess your application.
If requiring an adjustment for a disability, once selected for interview you may contact ukdiversity.recruitment@gsk.com

Thank you for your interest in this opportunity.

*LI-GSK

Contact information: 

You may apply for this position online by selecting the Apply now button.