Jawatan Kosong 2023 di National Institutes Of Biotechnology Malaysia (NIBM) | Permohonan adalah dipelawa daripada Warganegara Malaysia yang berkelayakan dan berumur tidak kurang dari 18 tahun pada tarikh tutup iklan ditawarkan untuk memohon jawatan kosong di National Institutes Of Biotechnology Malaysia (NIBM)
Positions:
1. SENIOR TECHNOLOGY OFFICER (HEAD OF GMP)
(Grade 8 - Contract) Malaysia Genome and Vaccine Institute (MGVI), Bangi.
Have the ability to perform the following tasks:
1. Leading and managing the cGMP QC, Production, QA teams to ensure compliance with quality standards and regulatory requirements;
2. Developing and implementing strategies for the timely and successful approval of new vaccine products by regulatory agencies and meeting the quality requirements of the organization;
3. Ensuring compliance with cGMP regulations and other relevant quality standards and maintaining up-to-date knowledge of these regulations and standards;
4. Collaborating with cross-functional teams to ensure that all aspects of vaccine development and production, including manufacturing, quality control, and testing, are in compliance with quality standards and regulatory requirements;
5. Overseeing the implementation and maintenance of quality systems, including documentation, record-keeping and training;
6. Managing relationships with external partners, including contract manufacturers, vendors and regulatory agencies, to ensure compliance with quality standards and regulatory requirements;
7. Involved with the continual improvement program of the facility;
8. Manage Technology transfer internally and externally; and
9. Staying up to date with the regulatory requirements and industry trends.
Qualifications and Experience:
1. Malaysian citizens;
2. The minimum qualification of a Degree in the field of Scientific/Engineering or a related field and recognized by the Malaysian government from a local or foreign higher education institution or a qualification recognized as equivalent;
3. Candidates with a master's degree or PhD academic qualification is an advantage;
4. At least 5 years of experience in supervising, maintaining the status of GMP status and managing the performance a Bio/Pharmaceutical cGMP facility;
5. Excellent leadership and communication skills, with the ability to effectively manage and mentor team members;
6. Must know and be familiar with regulatory requirements but not limited to such as PICs, WHO guidelines, and ICH requirements;
7. Must possess significant technical expertise in GMP operations within both Primary (API) and secondary operations as well as strong evidence of complex technical problem solving;
8. Must attend and be familiar with regulatory investigations and audits e.g., NPRA, FDA and other relevant authorities;
9. Experience in packaging, inspection, and storage of GMP-manufactured products are added advantage; and
10. Understanding of GMP area facility and utility maintenance Sterility assurance program, GMP equipment engineering, Validation and warehousing for cGMP-related materials and products are added advantages.
2. TECHNOLOGY OFFICER
(GMP Regulatory Affairs) (Grade 10 - Contract)
Have the ability to perform the following tasks:
1. Responsible for ensuring regulatory compliance for all manufactured products under th GMP facility;
2. Keep abreast with the latest regulatory requirements and changes in requirements for all materials used in the facility, to provide regulatory input/requirements to company management and regulatory guidelines;
3. Develop and Implement SOP, Forms and others related to the Regulatory department;
4. Prepare regulatory submission to regulatory authorities in compliance with regulatory requirements including new drug applications, clinical trial applications, and variations;
5. Interact with regulatory agencies during the development, registration, and post-approval phases of the product lifecycle;
6. Ensure compliance with local regulatory requirements, NPRA and assist during Internal audits, External audits and Regulatory inspections;
7. Manage regulatory activities related to product labelling to ensure compliance with regulatory requirements; and
8. Develop and implement regulatory strategies to support the development, registration, and post-approval maintenance of pharmaceutical products.
Qualifications and Experience:
1. Malaysian citizens;
2. The minimum qualification of a Degree in the field of Pharmacy is a registered Pharmacist in Malaysia under MOH and capable of obtaining and managing Poison A licensing of the premise
3. At least 2 years of experience in Regulatory Affairs in Pharmaceutical Industry;
4. In-depth knowledge of PICs guidelines, GMP requirements, ICH guidelines, Asean guidelines and OECD GLP testing guidelines;
5. Strong understanding of drug development including clinical trials and design and conduct are added advantages;
6. Experience in electronic documentation system related to product submission to NPRA;
7. Able to work independently and in a team as well; and
8. Possess great communication skills and critical thinking.
3. TECHNOLOGY OFFICER
(GLP Test Facility Manager) (Grade 11 - Contract) Malaysia Genome and Vaccine Institute (MGVI), Bangi.
Have the ability to perform the following tasks:
1. Ensure that qualified personnel, appropriate facilities, equipment, and materials are available maintain a record of the qualifications, training, experience and job;
2. Provide training for these functions’ guidelines for health and safety precautions are applied according to national and international regulations used appropriately;
3. Agree to the study plan in conjunction with the sponsor to ensure that amendments to the study plan are agreed upon and documented; maintain copies of all study plans;
4. Maintain a historical file of all Standard Operating Procedures; for each study ensure that a sufficient number of personnel is available for its timely;
5. Review, and approve test reports and documentation generated by the laboratory to ensure accuracy and reliability;
6. Ensure all laboratory equipment is maintained, calibrated and qualified as per regulatory requirements;
7. Work closely with Regulatory and Quality Assurance to ensure testing operations are compliant with regulatory requirements; and
8. Involved in providing technical guidance and support to laboratory personnel as needed.
Qualifications and Experience:
1. Malaysian citizens;
2. The minimum qualification of a Degree in Science in a related field and recognized by the Malaysian government from a local or foreign higher education institution or a qualification recognized as equivalent;
3. At least 2 years of working experience in a GLP testing facility. Added advantage if managing a GLP QMS system;
4. Thorough understanding of GLP regulation, guidelines and compliance;
5. Critical Thinker, good communication and analytical skills;
6. Familiar with equipment and test methods used in chemical, toxicology, biological and microbial testing; and
7. Familiar with setting up a new GLP QMS system.
4. OPERATION ASSISTANT
(GMP – Operation Assistant) (Grade 15 – Contract) Malaysia Genome and Vaccine Institute (MGVI), Bangi.
Have the ability to perform the following tasks:
1. Assisting in receptionists at GMP and GLP facilities;
2. Filing/Couriering of important files and biological samples;
3. Handling and managing company policies and records;
4. Coordinating company meetings, events and sessions with other department assistants;
5. Answering phone calls and other correspondences related to GMP and GLP vaccine facilities;
6. Assist in the preparation of reports or other compliance-related documents to vaccine facility GLP and GMP.
Qualifications and Experience:
1. Malaysian citizens;
2. The minimum qualification of an SPM certificate;
3. At least 1 to 2 years of working experience in Clerical is an added advantage;
4. Self-starter and willing to learn be help others;
5. Candidates must have positive attitude;
6. Excellent verbal and written skills; and
7. Able to work independently and as part of a team.
How to Apply:
Candidates who meet the requirements and eligibility conditions listed above are invited to send a complete resume including personal details, qualifications and experience, telephone number to contact, copies of relevant certificates and a passport-sized photograph (non-returnable) to:
HUMAN RESOURCE AND ADMINISTRATION DEPARTMENT
NATIONAL INSTITUTES OF BIOTECHNOLOGY MALAYSIA,
Pejabat Pentadbiran, Aras 1,
Kompleks Agro-Biotechnology Institute (ABI),
d/a Ibu Pejabat MARDI, 43400 Serdang, Selangor.
Tel: 03-8949 5620/03-8949 5648
Email:recruitment@nibm.my
Only shortlisted candidates will be contacted.
Tarikh tutup : 08 November 2023 (Rabu)
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Company Overview
The government of Malaysia has identified biotechnology as another potential area to be the engine of growth. In 2002, three interim laboratories - Genomic & Molecular Biology; Agro-Biotechnology; and Pharmaceuticals & Nutraceuticals were established to provide research infrastructure for the 8th Malaysia Plan for National Biotechnology Agenda led by the Biotechnology Cooperative Centres (BCCs).
The government of Malaysia has identified biotechnology as another potential area to be the engine of growth. In 2002, three interim laboratories - Genomic & Molecular Biology; Agro-Biotechnology; and Pharmaceuticals & Nutraceuticals were established to provide research infrastructure for the 8th Malaysia Plan for National Biotechnology Agenda led by the Biotechnology Cooperative Centres (BCCs).