Technical Service Executive - Project Green
Technical Services Executive
GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical and consumer healthcare companies and is committed to improve the quality of human life by enabling people to do more, feel better and live longer.
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.
We are currently recruiting for a Technical Services Executive to join our NPI & Technical Team. This role is mainly to ensure GMS KL's new and existing products technical inputs yield a robust process and deliver the highest quality product in a safe manner, delights our customers. At the same time taking into consideration of including but not limited to people capability development, formulation, starting materials, packaging components, equipment, process and testing.
- To assist the Technical Services Manager in ensuring that the requirements of the Site Validation Master Plan are effectively and efficiently implemented.
- Develop validation protocol, analyse validation data and prepare validation report for review and approval by Technical Services Manager and members of Validation Council.
- Involved in Validation Council to develop, review and approve qualification rationales, plans, protocols and reports.
- Responsible for validation activities in Solids packaging & manufacturing; Repacking
- Conduct packaging and manufacturing process validation and process understanding activities on new or existing products in accordance with procedures as required.
- Conduct equipment qualification in accordance with procedures specified/ governed in GSK validation guidelines.
- Develop validation protocol, collect and evaluate validation data and prepare validation report. Author and review validation documentation (User Requirements Brief / Specification, (URB/URS), Installation / Operational qualification documentation (I/OQ), and Performance Qualification (PQ)) for both large and small scale equipment, new technologies and systems.
- Execute cleaning validation on defined equipment as and when necessary.
- Conduct shipping trials exercises at site if and when necessary to support regulatory and process robustness initiatives.
- Management of all trials exercise at all Value Streams
- Conduct self-inspection for Technical Services Department and maintain technical compliance.
- Technical support (lead and part of a cross functional team) Global Supply products ranging from engineering to technical troubleshooting on new and existing products and troubleshooting in the factory, for manufacturing & packaging related issues.
- Develop process understanding to facilitate trouble shooting and coaching of technical knowledge to all site staff.
- Develop technical capability and competency across the production shop floor
- Co-ordinate the execution of complex manufacturing campaigns for NPI trails (including scale up) and Global supply development batches, interacting with numerous on-site and above site groups to meet pre-defined requirements.
- Typically work in a team of technical specialists and non-technical disciplines in a complex matrix environment, across and at various levels in the organization.
- Assist Technical Services Manager in managing any repacking of products.
- Highlight to Technical Services Manager on any relevant plant management issues, which may have potential impact on product quality or supply due to validation.
- Improvement of process capability within Manufacturing and Packaging Value Stream using Lean Sigma and Operational Excellence tools and techniques and identifying / driving / leading continuous improvement projects
- Bachelors of Engineering / Science / Pharmacy in Engineering, Packaging, Business Management, Quality & Compliance, Validation or equivalent
- Minimum 2 years' experience in manufacturing industries.
- Understand corporate Quality Policies, cGMP and validation concepts.
- Understanding of pharmaceutical production process, statistical process control and product knowledge and keep abreast of relevant pharmaceutical technology.
- Computer / data skill and analytical skill.
- Good people skills and good verbal and written communication skills
You may apply for this position online by selecting the Apply now button.
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