Operator - Injectable Filling Machines - Bausch+Strobel - Malaysia

About the Role

The DP Filling Aseptic Area Operator will be responsible for operating and maintaining pharmaceutical production equipment in aseptic conditions, ensuring compliance with GMP, GDP, and safety standards. This role involves handling drug product formulation, packaging, and transfer activities as per SOPs and batch records.

Responsibilities

• Set up, start batches, and operate pharmaceutical production equipment, including high-speed device manufacturing lines, automatic packaging lines, blister packaging lines, and inspection equipment Bausch Strobe Filling machines as per SOPs and batch records.
• Execute packaging activities for production batches, including formulation, dispensing, and dispatch of drug products.
• Prepare for changeovers, dispense and verify materials as per SOPs.
• Package and transfer final products to cold storage following SOPs and batch records.
• Complete all mandatory training prior to task execution.
• Adhere to GMP techniques and practices during packaging operations.
• Perform cleaning and upkeep of production equipment and classified manufacturing areas.
• Ensure timely completion of batch records and logbooks in compliance with GDP.
• Transfer materials for batch manufacturing as per SOPs.
• Load/unload batches from equipment during production activities.
• Conduct stock checks of consumables and report shortages.
• Follow safety and quality compliance at all times; promptly report anomalies to supervisors.
• Participate in EHS, Business Compliance, cGMP, and other compliance-related activities.

Qualifications

• Education: Master or Bachelors degree in Pharmacy, Science, or related field.
• Experience: 8 to 14 years in pharmaceutical manufacturing, preferably in aseptic filling and packaging operations.
• Job Location: Malaysia

Required Skills

• Knowledge of GMP, GDP, and cGMP practices.
• Ability to operate and maintain pharmaceutical equipment.
• Strong attention to detail and documentation accuracy.
• Good communication and teamwork skills.

Preferred Skills

• Compliance & Safety: Strict adherence to SOPs, GMP, GDP, and EHS guidelines.
• Ensure quality and safety standards are met at all times.