Operational Quality Manager
We are currently recruiting for an Operational Quality Manager to join our Global Manufacturing & Supply plant based in Ulu Klang. This role will mainly be responsible to plan, coordinate, lead and manage the activities of the Operational Quality section of GMS, KL to ensure that the relevant raw materials, intermediates and final products are manufactured, tested and released in full compliance with cGMP and regulatory requirements.
At GlaxoSmithKline (GSK) we are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer. GSK is one of the world’s leading research based healthcare companies, with over 100,000 employees in 150 countries across our Pharmaceuticals, Vaccines and Consumer Healthcare business.
We are proud of the difference we make and in 2016, FORTUNE Magazine ranked GSK #1 on its list of companies that are changing the world. The 'Change the World' list recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy. Put simply, our focus is on improving access and affordability of medicines, regardless of where people live or their ability to pay.
GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.
In Malaysia, GSK has established a strong presence for over 50 years and is home to our operations in the area of pharmaceuticals, consumer healthcare, manufacturing, and Business Services Centre. GSK employs over 1000 staff in Malaysia.GSK is an exciting, rewarding and dynamic place to work. We thrive to be different from the conventional corporate ways of working. We pride ourselves on exemplary leadership and sense of community, and we offer a great platform for your personal and career development.
GSK Global Manufacturing & Supply - GSK’s Global Manufacturing & Supply (GMS) plant produces leading consumer brands, services 13 global markets including Australia and New Zealand and is a leader in Good Manufacturing Practice and ‘Premise/Factory of Choice” for industrial excellence in the region
• Accountable for implementation and maintenance of Quality Assurance procedures and systems to ensure compliance to PIC/s cGMPs and corporate policies.
• Release products manufactured or packed in GMS KL in accordance with regulatory and GMP requirements
• Ensure that all attributes / elements contributing to product release decisions have been fulfilled promptly in accordance with requirements
• Ensure shift-based oversight of facilities, equipment and personnel to ensure compliance to procedures in real time
• Participate in on-line problem solving and conduct investigations together with Production, Engineering and Technical departments as required
• Recommend changes in practices to enhance the conformance to GMP within all departments at GMS, KL
• Conduct training in GMP and Quality / GMP related SOPs
• Work with counterparts at other sites to establish common (best) practices in quality related systems, policies and procedures
• Management of Product Complaints and Anti-Counterfeit activities at site
• Management and coordination of Deviations, product failures, product incidents and recalls for the Site
• CAPA (Corrective and Preventive Action) management for L1 self-inspections, deviations and product complaints. Monitoring progress against these actions
• Assist in leading and hosting audits and inspections
• Effectively deploying the requirements of the GSK quality organization at those contractor sites associated with GMS, KL and contractor sites as specified by the RQD whenever appropriate
• To apply the required communication, learning and recognition tools to the implementation
• To support the impacted target groups with implementation of QMS requirements
• Management of the Operational Quality budget to ensure achievement of operational targets
• Other duties as assigned by the QA Manager from time to time.
• Minimum Degree Holder in Pharmacy, Science, Engineering or equivalent.
• Minimum 4 years’ experience Quality Assurance and Management, GMP and QA requirements
• Minimum 7 years’ experience in the Pharmaceutical industry or associated industry
• Technical knowledge and competency in manufacturing and packaging processes
• Thorough knowledge of GMP and GLP
• Skilled at auditing
• Conversant at Quality Document Control System
• Skilled at Report writing
• Able to deliver training to small and / or large groups
• Able to influence others (persuasiveness and assertiveness)
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.
Why You?Basic qualifications:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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.