Operator - Injectable Filling Machines - Bausch+Strobel - Malaysia Employment -PVP

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

https://www.bioconbiologics.com

Role & responsibilities

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

Key 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 Syntegon, 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 & Skills:

• Education: Master or Bachelors degree in Pharmacy, Science, or related field.
• Experience: 4 to 8 years in pharmaceutical manufacturing, preferably in aseptic filling and packaging operations.

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.

Compliance & Safety:

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