Compliance Engineer

Job description

Details:
GSK have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer.

At Worthing, our focus is to manufacture and supply the broad spectrum antibiotic, Augmentin as oral tablets, suspensions and sterile injectable dose forms. The site has a complex operation with two orals and suspensions manufacturing areas, two packing areas with 12 lines, a bulk sterile manufacturing plant and two vial filling lines. There has been significant recent investment in the site including a new £120m bulk sterile facility due to come on line in 2019.

GSK's Worthing Secondary site is one of GSK's flagship penicillin secondary manufacturing sites, producing finished packs in oral, suspension and sterile dose forms. Worthing's product portfolio includes more than 600 different packs to meet customer demand, with the major finished products including Augmentin and Amoxil. You will directly contribute to the lives of patients receiving our products, by ensuring our facilities and manufacturing operations are safe, comply to the highest quality standards, and are lean and efficient.

The key purpose of the role is to champion the Quality Management System/ EHS framework and embedding quality principles within the Secondary Engineering department.

Key Responsibilities:

• Own and drive compliance with the Quality Management Systems and Safety systems within Secondary Engineering.
• Processes include but are not limited to: audits, deviation and CAPA management, QMS implementation and compliance, Change control, Engineering Alerts and safety reporting.
• Provide a strong link between Secondary Engineering, QA and the Operations departments.
• Drive compliance with Quality and Safety metrics and ensure data is collated and reported in a timely manner.
• Support the management for Quality and Safety meetings and Risk/ Audit meeting processes by taking an active role in defining the agenda, monitoring attendance and chairing the meetings when required. This includes taking meeting minutes and managing the action logs.
• To drive the Secondary Engineering risk management process, including management of the risk log ensuring risks are scored, escalated and tracked in line with procedures.
• Manage the Secondary Engineering PSSR inspections process in collaboration with the Engineering teams and the SAP Planning team.

Please note that this role is based in Worthing Secondary.

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

Closing date for applications: COB 11th June 2017

When applying for this role, please use the 'cover letter' of the on-line application 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.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Desired profile

Basic qualifications:
• Engineering degree and / or suitable pharmaceutical experience.
• Previous experience in Engineering or a related discipline i.e. Technical, Safety or Quality.
• Good knowledge of safety and GMP requirements.

Preferred qualifications:
• Sound understanding of Engineering processes and applications.
• Excellent communication skills.
• Experience of QMS systems and CAPA is highly desirable.
• Skills in data analysis and interpretation, Technical Writing.
• Computer literacy, experience in SAP processes desirable.
• Have experience and be comfortable working in a highly regulated environment.