Posted Date: Jan 3 2020
Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? If so, this Senior QA Executive role could be an ideal opportunity to explore.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
To provide QA oversight over Quality Control activities to maintain cGMP compliance in line with GSK and regulatory standards.
• Quality oversight:
a. Interact with QC personnel in day-to-day operations to ensure cGMP compliance in the following areas:
ii. Biochemistry & Microbiology
iii. QC Systems & Support including reagent qualification & logistics
iv. Analytical Systems & Analytical Technology Quality oversight:
- Support compliance in QC areas by regularly conducting shop floor visits for checklist review, housekeeping checks, review of line clearance checks (for selected areas), verify compliance with SOPs, etc.
- Provide quality input and assistance in managing unplanned event investigations, CAPA implementation and change control monitoring.
- Ensure changes implemented in QC areas are properly managed to prevent potential adverse impact to testing operations.
- Authorize QA processes, eg. Quality Tagouts, Conditional equipment releases, room releases etc
- Review and approval of the following documentation as assigned.
- Support site complaint investigation
- Degree in Science or Engineering or any related field
- At least 5 years of experience in Pharmaceuticals industry or in GMP regulated areas
- Extensive knowledge and hands-on experiences of pharmaceutical manufacturing processes
- Efficient communication skills
- Good understanding of GMP standard and regulatory requirements of pharmaceutical industry.
- User experience with SAP preferred.
- Basic understanding of regulatory inspection requirements.
What We Can Offer You
GSK’s dedication to the wellbeing of our employees is reflected in the benefits we offer; including healthcare for yourself and dependents, performance related bonus, long term incentives and a host of other flexible offerings you can tailor to your own preferences. We also offer a range of employee health and wellbeing programs including our truly unique Partnership for Prevention program, a global commitment by GSK to provide all employees with up to 40 preventative healthcare services bringing to life our mission to: do more, feel better and live longer.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
If you would like to join us in innovating and inspiring changes in the industry, we urge you to apply.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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