QA Operation (Contract)

Major Tasks

• Responsible for review documentation for batch disposition activity within Cimanggis site including batch report archiving.
• Handling investigation of non-conformity including deviation, complaint, out of specification and defect from supplier including assuring that the investigations according to the timeline are made to determine the root cause and actions are defined.
• Ensure corrective and preventive actions (CAPA) implementation in the shop floor based on investigation performed.
• Oversighting process in non-Operation area by involving in QA shopfloor activities to ensure the GMP compliance, food safety and halal compliance.
• Ensure the daily activity to be performed effectively and efficiently accordance with current regulations in Quality (GMP, GDP), Safety, food safety and halal system.
• Responsible to review the environmental monitoring result and report handling.
• Handling SOP relevant with QA Operation area particularly related to batch report and release documentation.
• Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within QA Oversight and Product Quality Assurance activities.
• Coordinating to evaluate HIRA (Hazard Identification Risk Assessment) of working area and ensure the completeness of HIRA training on the team and implementation of HIRA.

Skills & Requirements

• Pharmacist
• 1+ years’ experience in GMP aspects or related area.
• Having knowledge on international and local GMP principles for manufacturing of pharmaceutical products, Food supplements and Halal Management.
• Knowledge on occupational safety, health, and environmental requirements.
• Understands know how on current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes).
• Skilled to work and ability to work within teams.
• Professional English skills.
• Able to resist any influence which related to work matters