QA Compliance Auditor

Job description

Details:
GSK are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.

We have a significant global presence with commercial operations in more than 150 countries and a network of 89 manufacturing sites. Our global manufacturing and supply (GMS) teams are responsible for producing and shipping the products that help people do more, feel better, live longer. We have more than 27,000 people in GMS, across 36 countries and, together, these people help to produce 4 billion packs of medicine.

Our state-of-the-art facility at Barnard Castle is an integral part of our GMS organisation. The site produces some of the world's leading sterile, inhaled, topical and oral medicines for a wide range of diseases including leukaemia, HIV and MRSA. The site makes over 40 different products, exporting more than 90% of the 200 million packs produced each year to a global market place.

Situated in the heart of rural Teesdale, the site rests in a beautiful community located along the Tees River in County Durham. Both locally and within easy driving distance there is access to a multitude of recreational activities due to a close proximity to several national parks and local conurbations.

We are currently looking to recruit a QA Compliance Auditor to oversee site quality systems to ensure alignment and compliance with GSK internal procedures, policies, standards, local and global regulations. This challenging but rewarded role will carry out internal audits to identify risks, corrective and preventive action (CAPA) approval to tracking and, ultimately, ensure overall compliance.

The key responsibilities for this role are as follows –

• Perform Internal company audits, CAPA approval and tracking to ensure implementation
• Support the scheduling, execution and CAPA resolution of internal and third party quality system compliance audits
• Generate audit reports and conduct follow-up evaluations on corrective actions which address non-compliance audit observations
• Responsible for the inspection readiness status of the site for external audits
• Determine completeness of Regulatory Inspection Documentation
• Determine Inspection Strategies, responsible observation owners and adequate responses are written and put in place
• Act as advisor, facilitator and team member to QA and Barnard Castle site teams regarding regulatory compliance and quality systems for all aspects of manufacturing, filling, finishing, packaging and testing of biological products
• Be able to lead, manage and maintain the quality risk management process of the site
• Coordinate and investigate quality alerts for the Barnard Castle site and assure adequate
• Communicate audit related issues to internal stakeholders through appropriate escalation processes to ensure stakeholders understand technical, regulatory and quality risks
• Develop and publish linked metrics for Compliance activities to QA Site Management and Quality Council
• Determine Good Manufacturing Practice (GMP) compliance status of manufacturing, QA and support system operations
• Perform evaluation to ensure site compliance with regulatory and internal standards for all GMP activities at Barnard Castle
• Facilitate quality compliance process improvement within other departments, through the use of training, coaching and team participation
• Support continuous improvement activity, gathering facts & data, and recommend solutions and check effectiveness once actioned

In order to be considered for this exciting opportunity you will need the following skills and experience –

• Ideally possess a degree in a scientific or technical discipline (e.g. Chemistry, Pharmacy, Microbiology or Engineering). Demonstrable experience in a similar role will also be considered
• A proven track record of achievement within a QA Compliance orientated role in a high pressure, fast moving manufacturing environment
• Experience of scheduling and conducting site audits to identify, manage, correct and reduce significant risks/non compliance
• Knowledge of regulatory and quality system requirements and possess the ability to build relationships, explain, influence and negotiate with internal stakeholders to comply with standards
• Exposure to continuous improvement projects e.g. GMP, WCM, Six Sigma etc
• Be comfortable with building and maintaining relationships, cross functionally, in a matrix environment in order to effectively negotiate and solve problems
• Possess attention to detail paired with the ability to organise, prioritise and deliver tasks/projects with a sense of urgency, looking to drive change, whilst ensuring a focus on internal and external customers

Closing date for applications: Monday 19th June 2017.

If you are interested please apply as soon as you can.

When applying for this role, please 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.

*LI-GSK

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.

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:
See below

Preferred qualifications:
See below