Quality Assurance Assistant Manager

3 days ago

Kuala Lumpur, Malaysia AJ Research & Pharma Sdn. Bhd. Full time

**JOB SUMMARY**:

- Responsible for planning strategically to obtain marketing approvals at the earliest possible date and manage the provided resources to assure that the goals AJ Research Pharma are achieved while ensuring full local regulatory and company compliance.
- To support and assist for the organizational structure, roles and responsibilities for the Regulatory Affairs Department.
To support and assist the for profitability in immediate year and plan strategic long term goals to achieve.
- To ensure company operations are in compliance with all applicable government laws and regulations.
- To manage the routine Quality Assurance operations within the Affiliate for AJ Research Pharma and responsible for the development, training, implementation, and monitoring of quality systems for AJ Research Pharma.

**KEY ACCOUNTABILITIES**:

- Manage product registration, product maintenance and document retention and to ensure submission and maintenance of all regulatory files in 7 regions, Malaysia, Philippines, Vietnam, Singapore, Cambodia, Laos and Myanmar.
- Manage and facilitate new product registration and registration-related activities including prepare and review of product dossier, product classification, labelling and pre-submission compilation for Health Supplement, Cosmetic, Food, Traditional Products and Medical Devices in the said territories.
- Responsible as full-time liaison personnel with the government regulatory agencies and Ministry of Health. To represent the Company in the Regulatory technical advisory board, MOPI/PhAMA Regulatory Committee and MMDA Association.
- Arrange, monitor and manage the necessary regulatory submissions in facilitating lab testing at appointed labs as needed in 7 regions especially for Health Supplements, Food and Traditional products.
- To ensure there is prompt and effective communication both internally and externally to keep all interested parties informed proactively. This includes but is not limited to, superiors, counterparts, colleagues, principals and customers.
- Communication with RA Personnel and overseas authorities as required to ensure smooth registration process in the overseas region within the timeline.
- Work closely with authorities on submission and regulatory updates to ensure smooth process and expedition of the products submission timeline.
- Ensure proper filling and storage of documents for easy retrieval. Maintaining an up-to-date product database.
- Assist and handle regulatory implications amongst the 7 regions and undertake suitable regulatory planning.
- Maintaining and keeping up to date Health Supplement regulations and guidelines for the 7 regions in RA database
- Outlining requirement checklist for the 7 regions for Health Supplement registration dossier, samples, lab test and others as required
- Review and approval of Ad & Promo materials to ensure compliance with local regulations.
- To support following up on Corrective and Preventive Actions (CAPA) to ensure the required methods and timelines are successfully met.
- Ensure CAPAs identified during audits or other means are successfully resolved prior to commit due dates.
- Facilitate to ensure Quality management of Distributors per request.
- Take charge of internal/external QA relevant auditing. Maintain or ensure QA documentation is in place.
- Undertake all other tasks as assigned.

**REQUIREMENTS**:

- Degree holder in relevant field
- Compulsory to have a Pharmacist License
- 3 to 5 years of working experience in RA would be advantageous
- Highly competitive and self-motivated
- Good communication skills with a good working attitude
- Disciplined and able to work independently
- Good spoken and written communication skills
- Strong presentation and negotiation skills
- Confidence, tactful and a persuasive manner
- Good organisational and time management skills
- Delivers Results with Integrity: Meets commitments and produces the right results at the right time. Adheres to moral and ethical principles.
- Teamwork/ Supporting our colleagues: collaborates with co-workers to achieve workgroup and company goals
- Imitative: Acts without prompting or direction from others. Constantly strives to improve own and company performance.
- Personal involvement

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