Quality Control Manager
Salary MYR78,000 - MYR102,000 per annum + Market aligned
Location Shah AlamFULL_TIME
Consultant Shanggar Ganesh Marimutu
Date posted 19 July 20192019-08-13 2019-09-17 pharmaceuticals Klang MY MYR 78000 102000 102000 YEAR Robert Walters https://www.robertwalters.com.my https://www.robertwalters.com.my/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
An established international pharmaceutical company is looking for a Quality Control Manager to plan, organise, direct and evaluate the routine activities and deliverables of all QC analytical and microbiological activities and documentation to ensure the safety and reliability of products produced in compliance with quality, regulatory and GMP requirements. This position directly reports to the Head of Quality.
About the Quality Control Manager Role:
In this position, you will be responsible to manage the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the intermediate and finished good products, and the products’ stability studies.
- Oversee all daily aspects of QC laboratory including but not limited to sample collection, testing, and implementation/documentation of assays and microbiological tests
- Provide evaluation of the overall validity of the analytical and microbiological tests results reported
- Serve as the QC lead and provide analytical support to all related departments for analytical methods and manufacturing process technical transfers, in-process testing strategies, as well as analytical and process comparability assessments
- Establish continuous improvement of QC activities through regular reviewing of SOPs, test protocols and specifications
- Develop and implement assay monitoring and trending program focused on proactive assessment of method performance
- Oversee and monitor the QC laboratory to ensure that all QC-related activities and equipment operations are conducted with foremost consideration for safety and in compliance with GLP, by ensuring proper upkeep and maintenance of all laboratory equipment
- Ensure and promote compliance with applicable GMP regulations, internal corporate policies and company Standard Operating Procedures (SOPs), and ensure that all relevant SOPs are revised and updated in accordance to stipulated intervals
- Support product registration (local and overseas) through compilation and submission of test protocols, certificate of analysis and stability study reports to Regulatory Affairs Department
- Determine and maintain effective operations through proper budgeting and planning of QC activities/expenses
- Participate actively in activities involving QC department, including the self-inspection/self-audit programmes organised by QA department, 5S and Health, Safety & Environment (HSE) activities and external vendor/third party audits
To be successful in this role, you must have five years of quality control experience, preferably within the pharmaceutical, cosmetic or healthcare-related industry.
- Tertiary qualification in Chemistry/Pharmacy or equivalent
- Minimum five years of working experience in a quality control role within the pharmaceutical industry
- Proficient knowledge on quality control systems and equipment like HPLC, GC, FTIR and UV spectrophotometer
- Expert knowledge of current pharmaceuticals GMP guidelines
- Proficient knowledge in analytical testing of drug substances and formulations, and of computer systems for sample tracking, laboratory equipment, raw data handling and storage
- Strong problem solving and analytical skills with demonstrated ability to manage several projects simultaneously is a must
- Ability to effectively plan and organise work activities and prioritise task completion to adhere to schedules and deadlines
- Ability to work with multi-departmental team and personnel at various levels in the facility
- Excellent supervisory skills with the ability to coach and mentor staff in order to develop skills and competencies required to meet business needs
- Strong interpersonal and communication skills
With a presence within the pharmaceuticals industry for over a century, this company continues to be a market leader for their product category by being at the forefront of product innovation.
If you are seeking a challenging and driven Quality Control Manager role with a rapidly growing organisation with great prospects, this is the role for you.
Apply today or email me for more information at email@example.com
Agensi Pekerjaan Robert Walters Sdn Bhd
(formerly known as Robert Walters Sdn Bhd)
Business Registration Number : 729828-T
Licence Number : JTKSM 423C