Kerja Sepenuh Masa Assistant Manager, Research and Development, Gaji tinggi MYR 7,300 di Kenanga Network Selangor - Maukerja

QUALIFICATIONS:

• BSc or MSc in Chemistry or Pharmacy or any relevant science field.

EXPERIENCES:

• Possess at least 5 years of experience in pharmaceutical research and development.

CHARACTERISTICS:

• Good interpersonal and leadership skills, planning and organizing skills, and communication and analytical skills.

JOB PURPOSE:

To manage 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 assist in preparing, maintaining and monitoring NPD project timelines. 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.

RESPONSIBILITIES:

1. Research & Development / New Product Development (NPD)

· To manage 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 and review analytical method validation protocol and report for new products.

· To analyze, compile, review and present analytical data for technical discussion.

· To lead 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, maintaining and monitoring NPD project timelines.

· To prepare 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 review and report all analytical method transfer documents in compliance with pharmaceutical regulatory requirements and distribute to related person if required.

· 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.

4. Working Capital Management

· Managing budgets and costs effectively in respect of research and development activities by ensuring departmental expenditure is within agreed budgets demonstrating continual improvement in cost control without compromise to quality, safety and customer service.

5. Staff Development

· To ensure adequate and effective training for staff toward achieving the desired competency level.

· To be responsible in the development, training, discipline, working attitude and performance of staff according to procedures, policy and employment law.

· To provide training to staff from other department regarding product development, technical transfer and analytical method validation.

6. 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 perform duties on behalf of Deputy Director of Operation during his absence related to Research and Development department; excluding pharmacist responsibilities.

· Perform any other relevant duties as and when required by immediate superior and management.

· To participate in committee or any company activity appointed by the Site Director / committee leader.

Pay: RM4,700.00 - RM7,300.00 per month

Benefits:

• Additional leave
• Dental insurance
• Flexible schedule
• Free parking
• Health insurance
• Maternity leave
• Meal allowance
• Opportunities for promotion
• Professional development
• Vision insurance

Ability to commute/relocate:

• Rawang: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical Research and Development: 5 years (Required)

Work Location: In person