Kerja Sepenuh Masa Senior Executive, Research and Development, Gaji tinggi MYR 6,000 di GoodScience Selangor - Maukerja

QUALIFICATIONS:

Bachelor Degree in Science or any relevant field.

EXPERIENCES:

Possess 4-5 years of experience in pharmaceutical research and development and manufacturing.

CHARACTERISTICS:

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

JOB PURPOSE:

Responsible for coordinating the execution of the development of new products and technology transfer projects between the company, partners, and related stakeholders. Facilitate smooth transition of products from R&D to production, ensuring compliance with regulatory requirements, engaging stakeholders to achieve strategic objectives, and delivering projects within the business timeline.

RESPONSIBILITIES:

New Product Development

1. Project Planning and Execution

• Organize and coordinate project meetings, including preparing agendas, recording meeting minutes, and following up on action items.
• Develop detailed project plans and timelines for in-house and technology transfer initiatives by coordinating the planning, execution, and monitoring of assigned projects to ensure timely completion.
• Track formulation development, analytical method development/validation, process validation, stability studies, and registration activities.
• Timely updates and follow-ups to ensure clear communication and collaboration among all stakeholders.
• Prepare and maintain project plans, schedules, and status reports of project progress.
• Act as the primary point of communication among project team members, management, customers, suppliers, and other stakeholders.

2. Technology Transfer Management

• Support the transfer of processes, technologies, and documentation from R&D/partners to manufacturing.
• Ensure compliance with regulatory standards throughout the technology transfer process.

3. Dossier Submission Compilation

• Coordinate cross-functional teams to collect, compile, and maintain documentation required for dossier submission to HRS, ensuring compliance with regulatory requirements and project schedules.

4. Stakeholder Engagement

• Liaise with internal and external stakeholders to facilitate smooth project transitions.
• Prepare and deliver presentations to senior management and stakeholders on project status and outcomes.
• Distribute project updates, meeting agendas, and minutes to stakeholders.

Quality Management System

5. Documentation and Reporting

• Maintain comprehensive project documentation and ensure adherence to quality standards.
• To ensure all documentation related to Quality System maintained at all time.

6. Compliance

• To ensure all process regarding research and development activities align with regulatory standards (e.g., GMP, GDPMD, GDP, ISO Standards).
• Support the monitoring and coordination of change controls, deviations, CAPA, IR, and other Quality System processes, as applicable.

Others

7. Support for New Business Expansion

• Assist in projects (where applicable) related to new business expansion, including initiatives for new dosage forms, external collaborations, and other related activities.
• Facilitate communication among relevant stakeholders to ensure clarity and timely dissemination of information, as needed.

8. Other Key Responsibility

• To undertake any other duties as directed by the Immediate Superior and Management, as and when required.
• Ensuring communication between department is on-going and utilized to maintain an environment of continuous improvement.
• To participate in committee or any company activity appointed by the Site Director/committee leader.

Pay: RM4,000.00 - RM6,000.00 per month

Benefits:

• Additional leave
• Dental insurance
• Flexible schedule
• Free parking
• Health insurance
• 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 & Development and Manufacturing: 4 years (Required)

Work Location: In person