Qualified Person

Job description

Basic qualifications:

What qualifications do I need to apply?
You will have a degree or equivalent level in a scientific discipline and will be eligible for nomination as a Qualified Person (QP) within the EU
What experience do I need?
You will be experienced in sterile product batch release and of working within the pharmaceutical industry and have experience of managing people.

Preferred qualifications:

Other job related skills and experience:
• Qualified Person status (either by Permanent Provisions or Transitional arrangements)
• Knowledge and experience of audit processes, preparation and requirements.
• Comprehensive knowledge of regulatory requirements, operations in manufacturing areas and of laboratory testing including out of specification investigations.
• An understanding of computer system validation.
• Working knowledge of relevant Site systems, e.g. SAP or equivalent
• Computer Skills – Excel/PowerPoint/Word.
• Able to lead and work within Teams
• Strong interpersonal skills.
• Ability to forge excellent working relationships from Value Stream Director level downwards.
• Ability to plan, organize and control workloads to meet deadlines and deliver schedule and targets in an environment of change.
• Understanding / ability to demonstrate use of problem solving and continuous improvement techniques
• Ability to make decisions in a timely manner.
• Attention to detail at all times.
• Excellent communication skills at all levels both written and verbal.
• The ability to present information in a clear and concise manner in order to support decisions and at audits

Details:

What is my purpose?
You will be the Qualified Person on the site's Manufacturing Authorisation and will be active in providing an efficient service for the certification/release of intermediate and Finished Pack batches in accordance with EU and U.S. GMP.

You will be working 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.

You will provide technical expertise to support improvement activities and resolve quality issues.

What will I be responsible for?
You will uphold the professional responsibilities arising from being the QP named on the site Manufacturing Authorisation.

You will be expected to deputise for Site Quality Director for Deviation and CAPA Management

You will be responsible for assuring the safety, quality and efficacy of intermediate and finished pack batches released from site.

You will liaise with other Quality Unit groups to ensure that all other aspects of testing and validation have been completed before batch release.
You will maintain a compliant and efficient service for the release of manufactured batches ensuring that documentation standards are met within the manufacturing areas.

You will be expected to resolve issues related to any unplanned changes/deviations that may occur during manufacture, support key Quality system processes across the site including investigations, deviation clinics, root-cause analysis workshops and verification of CAPA.

You will support Level 2 audit schedules as an auditor or through CAPA development/ verification as well as supporting the Level 3 & 4 CAPA verification process.

What are the salary and benefits?
PAY
In return for your hard work we will offer you a competitive salary, can we ask that you please state your expectations in your cover letter.
In addition to your salary you will also be eligible for a target bonus of 18%

HOLIDAY TIME
You will receive 26-days paid holiday, your holiday will increase to 27-days after 5-years and 28-days after 10-years.

CAR ALLOWANCE
I f you are recruited as a grade 6 QP your Total Reward package will also include an annual car allowance of £6,252.

GOOD HEALTH & LIFE
We will offer you personal healthcare cover with the option to purchase cover for your family and an annual health MOT.

On this note we should make you aware at this point that Worthing is a penicillin manufacturing site.

SHARES & SAVINGS
GSK contributory pension
Shares & savings schemes
Employee assistance programme
GSK Total Reward Discounts
Tax free plans

DEVELOPING YOU
You and your line manager will meet regularly to ensure you develop with us and have a fulfilling career with GSK.

How do I apply?
Applications accepted until midnight on 9th March 2016
To apply for this role, please use the 'cover letter' of the on-line application to sell yourself to GSK and 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.

Thank you for your interest in this opportunity.

*LI-GSK

Contact information:

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