Site Name: Singapore - Quality Road
Posted Date: Nov 15 2019
Are you energized by a Quality Assurance role that allows you to accelerate compliance in a highly technical and regulated environment? If so, this Operational QA Staff role could be an exciting opportunity to explore.
As a Quality Officer, you will be responsible to ensure that products manufactured are in full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements so as to meet stipulated product quality standards in line with the established specifications of the organization.
This role will be based in Quality Road.
This will be a permanent role.
Other Key Responsibilities would be:
- Review batch and quality documentations to assess whether the product is fit for purpose prior to making usage decision.
- Assess, review and approve changes that may have an impact on product quality, validation and/or cGMP compliance to ensure timely product release to customers. Upon implementation of changes, review and ensure proper closure of changes.
- Lead investigation of product incidents and GMP deviations so as to drive for root cause identification and corrective and preventive action.
- Inspect and release process equipment/plant after turnaround.
- Assess, review and approve all cGMP related documentation.
- Co-ordinate and compile Periodic Product Review assigned
- Support site audit inspection preparation and participate as an audit team member in audits, including level 3 (e.g. MIA) and 4 (e.g. FDA) audits.
- Draft, compile, review and update appropriate procedures and listing relating to GMP and operational quality.
- Mentor and train new recruit of Quality Officer as required
- Update Technical Terms of Supply/Quality Agreement and issue Technical Terms of Supply/Quality Agreement change control to customer as needs arise.
- To rotate with other Quality Officers and to serve as SAP Business Process Expert for the Quality Module when the need arises to support Business.
We are looking for professionals with these required skills to achieve our goals:
• At least an honors degree in a relevant science discipline.
Senior Quality Officer:
• At least 5 years of relevant experience in the pharmaceutical industry.
• Entry level candidates, preferably with 1 - 2 years of industry experience
- If you have the following characteristics, it would be a plus:
- Associated Degree or Bachelor's degree
- Previous leadership experience is
- Experience addressing technical business solutions
- Strong verbal and written communication skills
- Proven experience assuring compliance with regulations
Our values and expectationsare 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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