Job Summary:To conduct analytical method development, analytical method validation, stability studies, comparative dissolution profile study, method transfer, finished product testing of trial batches and evaluation of new raw materials (API and excipients). To provide technical support to other cross-functional departments such as Production, QA, QC and RA and ensure all activities conducted in accordance to GMP, GLP and GDocP.
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- Research & Development / New Product Development (NPD)_
- To conduct analytical methods development for new products/ raw materials thereby ensuring method feasibility in analytical laboratory.
To execute analysis for new products/raw materials assigned.
- To carry out comparative dissolution profile for all medium and study on discriminating media or biorelevant media of innovator and in-house samples.
To carry out raw materials evaluation and analysis of new sources as required.- To carry out finished product and stability study analysis as per scheduled.
To prepare analytical method validation protocol and report for new products.
- To analyze and compile analytical data for technical discussion.
To act as R&D representative during method validation/verification/transfer and troubleshoot and deliver well-grounded solution to solve testing problem and instrument related failure.- Communicate and coordinate with third party labs on all relevant analytical activities.
To provide support in handling OOT and OOS investigation, when extended to R&D.
- Assist in forecasting analytical development financial budgetary planning.
To assist in preparing documentation related to trial/pilot batches eg trial/pilot batch report.- To support department in preparing product dossier for regulatory submission.
_2. Technology Transfer
_- To prepare analytical method transfer documents eg protocol and report in compliance with pharmaceutical regulatory requirements and distribute to related person if required.
To perform analysis process according to the applicable method transfer protocol from clients.
- Liaise with QC department for method transfer of new technology transfer product from clients.
To carry out inter-laboratory proficiency test and transfer analytical method to Quality Control department.- To take part in product improvement projects as required.
_3. GMP and ISO Compliance
_- To ensure all processes regarding research and development are in compliance with Good Manufacturing Practice (GMP), Occupational Safety and Health (OSH), and Environment.
Ensure all activities comply with GxP and other related regulatory requirements.
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4. Other Key Responsibility_
- Where applicable, to manage chemical inventory, purchase, storage and disposal related to R&D.
To provide technical support to other cross-functional department such as Production, Quality Assurance, Quality Control and Regulatory Affairs departments.- To prepare or revise relevant SOP.
To ensure all documentation related to Quality System maintained at all time.
- To execute other tasks or assignment as assigned by superior and/or Head of Department.
Job Types: Full-time, Permanent
Pay: RM3,000.00 - RM5,000.00 per month
Benefits:
Free parking Maternity leave
- Opportunities for promotion
Professional development
Schedule:
Application Question(s):- Do you have good knowledge in ISO
Do you have experience with Good Manufacturing Practice (GMP)
Education:
Experience:
* Pharmaceutical Research and Development: 3 years (Preferred)
