Job Description:

Production Executive is required to be an effective production operator to ensure his/her achieves the highest possible standards of excellence in all his/her responsibilities and performance. He/She is responsible to ensure a product or service meets the established standards of quality including reliability, usability and performance.

A) Operations

• Responsible for all aspects of GMP-production related operations (production activities), documentations, and administration:

1. Support the implementation of quality assurance standards.
2. Evaluate and review adequacy of quality assurance standards which are relevant to production.
3. Plan and execute production activities.
4. Support the investigation of customer complaints and non-conformance issues.
5. Identify self-training needs for production related activities to meet GMP standards.
6. Assure on-going compliance with quality and industry regulatory requirements on any production related activities.

• Execute multiple concurrent projects that will require flexible working hours.
• Adhere to the company’s policies, and standard OSHA (Occupational Safety & Health Administration) at all time while working in the company’s premises.
• Provide production-related training for new staff.

B) Regulatory

• Participate in the development of production-related SOPs and its implementation to ensure regulatory requirements are met.
• Participate in facility and instrumentation’s DQ, IQ, OQ and PQ.
• Support other regulatory-related duties as necessary.

C) Administrative Obligation

• Production executor.
• Reporting to Production’s Manager/HOD
• Attend department’s meeting.
• Generate reports as per instructions from superior.
• Attend relevant seminar/workshop/conference.
• Monitor stocks of materials for production and operation.
• Execute production-waste management as per SOPs.

D) Self-Improvement Obligation

• Continuous learning through activities endorsed by company.
• Attend technical training/workshops/seminars endorsed by company.
• Attend scientific/relevant conferences endorsed by company.

E) Health and Safety Requirement

• Employees must ensure they do not compromise the safety of themselves or others by means of:

1. Actively participating in health and safety awareness programmes.
2. Following company’s safety procedures and rules.
3. Behaving and acting safely.
4. Reporting near misses, accidents and unsafe situations.
5. Actively participating in rehabilitation.

F) Others:

• Assist internal staff in all aspect of processes, analytical development/optimisation, qualification, validation as per requirement.
• Assist superior as per requirement.
• Assist team member as per requirement.
• Maintain confidentiality of company’s information as per requirement.

Job Qualification:

• A background in basic cell culture or biotechnology.
• Understanding of basic GMP concept.
• Ability to manage and organise.
• Attention to detail.
• Good problem-solving skills and critical thinking.
• Planning and organising.
• Proficient in writing, and publishing scientific reports/papers.
• Excellent computer skills.
• Strong communication skills, including the ability to explain and teach methodologies.
• Open to change and learning new systems.
• Ability to ensure quality guidelines are being followed.
• Professional and mature approach at all times.
• Flexible due to work demands.
• Effective planning and time management processes to ensure efficient use of resources.