Periodic Product Review (PPR) Coordinator

Job description

Details:
Every product produced at the GSK Ware GMS (Global Manufacturing and Supply) site undergoes periodic product quality reviews to verify the consistency of the existing process, highlight any trends and identify product or process improvements. The Periodic Product Review (PPR) Coordinator is responsible for generating and maintaining these annual Product Quality Reviews.

Job Purpose & Key Responsibilities:
You will be responsible for generating circa 50 key PPR documents annually and will be expected to coordinate and track the progress of these activities to ensure that timelines are met. You will work with members of the Quality and Technical functions to ensure that the documents produced comply with GSK's quality standards and well as meet Regulatory expectations.

Day to day activities include:
• Collation and interpretation of product related information into a report format;
• The extraction of data from a number of source systems;
• Collation and analysis of data using statistical analysis tools;
• Liaising with Data Management team to identify data and secure final data analyses;
• Leading review meetings and communicating the output to a cross-matrix team.

Additional responsibilities
• Perform reviews of the PPR process to ensure compliance and to suggest improvements based on these reviews to the PPR process
• Support and provide requested documentation for internal and external audits/inspections. Ensuring function maintains audit readiness and completes regulatory audit actions in a timely manner
• Archiving of all electronic files relating to PPR documents and hard copy PQR reports in accordance with the global records retention policy

About You:
This role would suit a self-starting, detail-orientated individual who has strong experience of working in a GMP (Quality) environment. You will have a strong continuous improvement mindset and a willingness to work towards standardised and lean working practices. You must be able to work well in a co-operative team environment and be an effective communicator.

About GSK:
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com

About Ware Manufacturing Site:
Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products. This must be achieved whilst consistently delivering outstanding quality, service and value to our patients.

Applicants must demonstrate in their application how they meet the above criteria in order to be successful for interview selection.

Closing date for applications: Wednesday 12th April 2017 (COB).

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter' of the online application or your CV to 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 and CV will be used to assess your application.

If requiring an adjustment for a disability, once selected for interview you may contact

*LI-GSK

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

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Desired profile

Basic qualifications:
Relevant qualifications and / or experience is essential
Good understanding of SAP and related systems
Extensive experience of using Microsoft Office packages to produce GMP documents
Required to demonstrate competence in current Good Manufacturing Practice (cGMP), as well as understand its impact on their own role and the importance of cGMP.

Preferred qualifications:
As per Basic Qualifications