Q&V QA Executive

Sunward Pharmaceutical; Johor Bahru; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading pharmaceutical company in Johor Bahru is looking for a professional to oversee process validation and qualification of production equipment. The role includes responsibilities such as conducting temperature mapping studies, preparing validation protocols, and ensuring compliance with regulatory standards. Ideal candidates will hold a Bachelor’s degree in Science or Pharmaceutical, have knowledge of GMP/ISO9001, and demonstrate strong communication skills. Join us and contribute to maintaining high quality and compliance standards.

Qualifications

• Bachelor’s degree or professional degree in Science/Pharmaceutical or equivalent required.
• Knowledge in Quality Management System, GMP, or ISO9001 is an advantage.
• Well versed in documentation handling.

Responsibilities

• Responsible for process validation, cleaning validation, and equipment hold time studies.
• Coordinate and oversee temperature mapping studies for storage areas.
• Prepare, execute, review, and approve qualification and validation protocols.

Skills

Quality Management System (GMP/ISO9001)

Documentation handling

Excellent communication skills

Excellent writing skills

Education

Bachelor’s Degree in Science/Pharmaceutical

Job description

Responsibilities

Responsible for process validation, cleaning validation, equipment hold time (clean & dirty), and hold time studies.

Responsible for qualification of production equipment, premises, and critical utilities, including preparation, execution, and review of qualification activities.

Coordinate and oversee temperature mapping studies for storage areas.

Prepare, execute, review, and approve pre- and post-execution qualification and validation protocols and reports.

Review and monitor the qualification and validation status of equipment, facilities, and critical utilities.

Responsible for the Validation Master Plan (VMP) of the facility and oversee all Qualification & Validation activities.

File incident reports/deviations, conduct investigations for validation-related issues, and propose, implement, and follow up on CAPA actions.

Review and check Batch Manufacturing Records (BMR).

Perform walkabouts to ensure facility and operations comply with GMP and regulatory requirements.

Support internal and external audits, ensuring procedures and practices comply with regulatory and quality system requirements.

Draft, review, and revise SOPs for the QA department and other departments as required.

Provide basic GMP training and assist in training new personnel within the Qualification & Validation team.

Oversee and support new equipment installation, process changes, and upgrade activities, ensuring compliance with GMP requirements.

Qualifications

• Minimum in Bachelor’s Degree or Professional Degree in Science/ Pharmaceutical or equivalent.
• Knowledge in Quality Management System e.g. GMP/ ISO9001/ etc is added advantage.
• Knowledge in Qualification & Validation is added advantage.
• Well versed in documentation handling.
• Excellent communication and writing skills.