Quality Oversight Officer

Job description

Details:

We are 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 close to 100,000 people globally, we have 87 manufacturing sites around the world.
Our pharmaceuticals business researches, develops and makes available medicines that treat a variety of serious and chronic diseases. We have medicines available or in development in a wide range of areas including:

• infectious diseases
• cancer
• epilepsy
• heart disease
• asthma and chronic obstructive pulmonary disease
• HIV/AIDS

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.

Job Purpose:
To ensure products released to market conform to registered standards and are manufactured to cGMP standards. Provide quality oversight of manufacturing areas and be the first line of contact for quality assurance advice supporting production and engineering.

Key responsibilities:
• To ensure product is manufactured to cGMP standards by checking that production and engineering activities consistently follow quality management processes and are in line with GSK policies and guidelines.
• By observation of production and engineering activities, monitor compliance with cGMP principles and GSK QMS and propose necessary corrective measures.
• Review production processes to assure compliance with Site and local procedures.
• Identify gaps between SOPs and current practices; ensure action is taken to rapidly resolve also working with Quality Managers to ensure product quality implications are considered and acted upon.
• Drive for early detection and help prevent potential quality issues.
• Be the first line of contact for quality assurance advice and support for production and engineering.
• Support initial investigations into deviations including identification of remedial actions and causes, ensuring that appropriate containment actions are taken by production.
• Support production and engineering to ensure that any deviation from GMP or company standards are fully documented to ensure an accurate and focussed investigation can be performed.
• Promptly communicate potential or existing quality issues to product stream quality managers, technical etc as applicable to ensure correct remedial actions and CAPA implemented.
• Review CAPA implemented in production and engineering to ensure it is in place and in use.
• Share learnings with key site personnel and ensure there is communication to management.
• Review in-process production and engineering documentation to verify accuracy and timely recording of GMP activities.
• To support the Operational Quality group by performing documentation reviews for approval/release of product to market.
• To support Quality Managers by performing QA review and approval of local standard operating procedures, batch documentation and engineering maintenance routines.
• Support Quality Managers to ensure all changes in established production and engineering processes are managed through the appropriate change control processes. Check required testing and monitoring has been completed prior to QA review and approval.
• Participate in self-inspections of QA processes and support production and engineering self-inspection activities.
• Participate in the investigation and reporting of customer and vendor complaints.
• Comply with applicable Environmental, Health and Safety requirements.

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

Closing date for applications: Friday 8th July 2016

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.

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:

• Graduate (or equivalent) qualification in a scientific or engineering discipline
• This role requires shift work, this role will be on LEN ( Lates, Earlies, Nights)

Preferred qualifications:

• Knowledge of current Good Manufacturing Practice requirements within major pharmaceutical markets.
• Knowledge and application of the principle of Quality Management System (QMS).
• Demonstrated inquisitiveness and ability to challenge a situation.
• Effective written and verbal communication and interpersonal skills to enable close liaison with production, engineering and QA staff.
• Attention to detail.
• Ability to organize and prioritise workload.
• Ability to coach staff.
• Computer literate (MS Office – word, excel, power point)
• Experience in the pharmaceutical industry – preferred.