Operational Quality Executive

Operational Quality Executive

GlaxoSmithKline Pte Ltd
Kuala Lumpur Selangor
Not Specified
Not Specified

Job Description

Job Description :
GlaxoSmithKline (GSK)is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.GSK has been operating for over 60 years in Malaysia and grown substantially both in its infrastructure, business operations as well as talent base spreading across its four business entities – Pharmaceuticals & Vaccines, Consumer Healthcare, Business Service Centre and Consumer Healthcare Supply Chain.
We are currently looking for experiencedOperational Quality Executive to be part of our Consumer Healthcare Supply Chain business and this role will be based at Ulu Kelang office. You will be accountable for Accou implementation and maintenance of Quality Assurance procedures and systems to ensure compliance to ISO 13485, PIC/s and corporate policies.
Other Key Responsibilities:
  • To act as Quality liaison person during the shift operation at operational area including Production, Warehouse, QC Laboratory and Facilities area
  • To advise on all aspects of GMP compliance and facilitating finished product release and assess the quality impact.
  • To conduct In-process Quality Checks at the production floor as per SOP requirements (for packing operation).
  • To review batch record completion and retain sample to ensure batch is produced in accordance to the procedure and perform approval in SAP as Authorised Person (AP).
  • To participate in on-line problems solving and conduct investigations for Product Complaint and Deviation as required.
  • To identify and manage the risk at respective Operational Quality scope and area.
  • Product Reviewer for Periodic Product Review at site.
  • To involve in audit preparation for Operational Quality section.
  • To conduct Level 1 audit for areas of concern
  • Authorized Person (AP) and perform all task relevant to batch release process including approval of batch in MERPs, preparation of CoA, retain sample review.
  • To provides the system of assurance that establishes systematically that all products released for sale is both fit for purpose, efficacious and compliant with all internal and external regulatory requirements.

Why you
We look for people who appreciate the importance of safety and quality and strive to continuously improve our performance and practices. We work in an open and transparent environment so you’ll be someone who treats others with respect and integrity – as you will be treated yourself.
Ideally, we are looking for someone with:
  • Bachelors Degree in Science / Engineering / Pharmaceutical / Technology or equivalent​
  • Minimum of 3-4 years of Manufacturing and/or Quality Assurance experience.
  • Experience and having technical knowledge including Good Manufacturing Practices (GMP) / GLP
  • Exposure and familiar with auditing

  • Able to work on 3 shifts (morning, afternoon, night) on weekly rotational basis

  • This role requires to work on weekends and public holiday (following production schedule)

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, etc. 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 online.
Our goalis 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.
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.

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