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 our GMS plant in Jurong. Please note that this is a 12 months contract 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 VS Quality Officer:
• At least 5 years of relevant experience in the pharmaceutical industry.
VS Quality Officer:
• Fresh graduates, 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 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
*This is a job description to aide in the job posting, but does not include all job evaluation details.
Why You?Basic qualifications:
Senior Quality Officer:
• Extensive knowledge of GMP and validation.
• Extensive knowledge of quality and manufacturing processes.
• Good knowledge of corporate management systems.
• Good audit skills.
• Detailed knowledge of regulatory processes
• Good knowledge of GMP.
• Good knowledge of quality and manufacturing process knowledge.
• Basic knowledge of corporate management systems.
• Good audit skills.
Candidate should have good work ethics and is driven to learn and work in a manufacturing environment.
GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its ‘Change the World list’ which recognizes companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.
GSK was the first pharmaceutical company to set up manufacturing operations in Singapore, growing to be one of GSK’s largest manufacturing centers outside of the UK.
The Jurong facility manufactures 16 active pharmaceutical ingredients used in a variety of GSK prescription medicines for the treatment of respiratory, HIV, gastro-intestinal, allergy, anti-viral and neurological conditions.
You may apply for this position online by selecting the Apply now button.
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