Shift Operational Quality Adviser (Worthing Primary)

Job description

Details:
GSK is a leading global healthcare company with a challenging mission – to help people to “do more, feel better and live longer”

At our Worthing Primary Operations site we produce critical bulk raw materials and Active Pharmaceutical Ingredients (API) used in medicines across the globe.

We have recently introduced a number of new Operational Quality Assurance jobs to work on Shift work alongside our shift based production operators and engineers. Your will be the first line of contact for operational quality advice and support to help drive Quality Compliance requirements across all of our processes.

We think these offer a fantastic opportunity for experience Quality Assurance Professionals with demonstrated experience in embedding cGMP, to make a real difference onsite, and to achieve a high level of expertise in cGMP and API Processes.

At GSK we are inspired by the difference we make and challenge ourselves every day to improve the lives of patients and consumers. That's why we have created an environment where everyone feels valued, able to develop, contribute to our mission and be proud of what we achieve.

Your job will be to ensure that the API products we produce conform to registered standards and are manufactured to cGMP standards. You will provide quality oversight of manufacturing areas and be the first line of contact for quality assurance advice supporting production and engineering.

You will drive for early detection and help prevent potential quality issues, and will include responsibility for reviewing incidents in manufacturing to determine correct categorization, investigation and Quality oversight.

We work in a fast-paced and highly regulated environment. A continuous improvement mindset is essential for this role, as is the ability to coach, mentor, problem solve, influence and effectively communicate with all levels across all functions across the site to achieve the best outcomes for GSK.

In return, we'll provide you with a personalized development plan to ensure your personal career development goals are met. Working with a small validation team onsite offers opportunities to develop and embed your skills across a number of specialist areas.

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 cGMP 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 cGMP 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.

What's on Offer?
To support you in achieving your role and career ambitions you'll be given the opportunity to:

• Play an important role in delivering our mission
• Be an essential part of diverse, global team
• Develop others as part of your own professional growth

You'll receive a competitive salary package with 33.3% shift allowance, on target bonus, private medical insurance, generous Company Pension Plan, a share purchase scheme, 26 days annual holiday and plus a personalized career development pathway.

This is a SHIFT based role as follows:
=> 42 hours per week with 2 x days, 2 x nights followed by 4 days off
=> 33.3% shift premium applied to basic salary

How do I apply?

Please apply now via our online portal using your cover letter and CV to tell us more about you and why you're the perfect person for the role. (Please take a personal copy of the Job Description, as this will not be available online post closure of the advert)

Closing Date: Mid-Day on Friday 25th Nov 2016.

PLEASE NOTE: You MUST BE ELIGIBLE TO WORK IN THE UK without sponsorship.

Please note: If you require 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:
This role requires you to interpret scientific data, assess risk, make decisions and communicate effectively so you should hold a relevant scientific Degree or HNC/HND Equivalent.

You will have experience of working in a regulated industry, experience of Quality management systems and will of take the role of mentor and coach.
• Experience in a pharmaceutical manufacturing organization
• Proven coaching and mentoring skills and experience.
• A good understanding of the skills required for technical, operations, engineering and quality staff.
• Knowledge of current Good Manufacturing Practice requirements within major pharmaceutical markets.
• Knowledge and application of the principle of Quality Management System (QMS).
• The ability to interact and communicate well with teams across site
• Experience in delivering change management and continuous improvement
• Positive proactive attitude, ability to work independently and as part of site teams.

• 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

• Experience of performing Quality audits
• Lean Sigma green belt
• Track record of collaborative working relationships across reporting lines
• Will be a ‘shop floor' based but not formal auditing
• Will be based in operations and not an office based role
• Will Follow the GPS standard work approach
• Will attend shift handovers
• Will have experience in other relevant roles prior to taking on this role (not entry level quality role)

Preferred qualifications:
See above