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Quality Management Systems

GSK
, Malaysia - Ulu Kelang
35 days ago: GSK

Job Description

Your Responsibilities :
We are currently recruiting for a Quality System Manager to join our Quality Team under the Global Manufacturing and Supply site. This role will mainly be responsible to Responsible for the site and Quality System Management and accountable for implementation and maintenance of Quality Assurance procedures and systems to ensure compliance to PIC/s and corporate policies.
The Role
• To plan, coordinate, lead and manage the activities of the Quality System Section of GMS KL, this includes:
• Manage and lead Self-Inspection and Internal Audit process
• Manage and lead site L3 and L4 quality audits and coordinating on CAPA completion of such audits
• Governance of CAPA, Quality Alert and Change Control process
• Governance of site quality KPIs reporting activities
• Manage and lead Site Quality Plan, Quality Risk Model activities
• Governance of CARISMA3 System
• Training in GMP and Quality / GMP related SOPs
• Recommend changes in practices to enhance conformance to GMP
• Provide coaching in GMP and Quality / GMP related SOPs
• To lead and prepare site to maintain ISO 13485 certification
• Management of Quality System budget to ensure section spend within budgeted allocation
Requirements
• Bachelor of Science or equivalent.
• Minimum 5 years of working experience in manufacturing, preferably with managerial skills.
• It is an essential to understand the manufacturing environment and managing a section with confidence.
• Experienced in a Pharmaceutical industry.
• Auditing skills
• Change control Management
• Possess good interpersonal, motivational and communications skills to allow effective liaison with in house and external parties.
• Willing to learn attitude
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.
Application Process
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:


Preferred qualifications:


Why GSK? :
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


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Your Responsibilities : We are currently recruiting for a Quality System Manager to join our Quality Team under the Global Manufacturing and Supply site. This role will mainly be responsible to Responsible for the site and Quality System Management and accountable for implementation and maintenance of Quality Assurance procedures and systems to ensure compliance to PIC/s and corporate policies. The Role • To plan, coordinate, lead and manage the activities of the Quality System Section of GMS KL, this includes: • Manage and lead Self-Inspection and Internal Audit process • Manage and lead site L3 and L4 quality audits and coordinating...