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Sterile Form Production Technician

2 months ago

Candiac, Quebec, Canada Pharmascience Full time

About the Role:

Pharmascience is seeking a highly skilled Sterile Form Production Technician to join our team. As a key member of our production team, you will be responsible for performing manufacturing and filling steps for injectable products, as well as assembling, operating, and disassembling production equipment.

Key Responsibilities:

  • Inspect and prepare production areas to ensure a clean and safe working environment.
  • Assemble, adjust, and disassemble equipment used in production, ensuring proper functioning and maintenance.
  • Perform tasks described in production files and complete them accurately and efficiently.
  • Prepare cleaning solutions, wash equipment, and rooms related to production, adhering to Good Manufacturing Practices (GMP).
  • Prepare equipment for sterilization and depyrogenation, ensuring compliance with regulatory requirements.
  • Keep logbooks up to date, accurately recording production activities and equipment maintenance.
  • Perform production tasks from receiving materials to filling and crimping products, including weighing ingredients, mixing, filtering, taking samples, filling, and crimping.
  • Collaborate with supervisors and stakeholders from other departments to ensure work is done according to GMP.
  • Check, maintain, and calibrate production equipment, ensuring optimal performance and efficiency.
  • Write procedures related to production and follow training programs, staying up-to-date with industry developments and best practices.
  • Maintain equipment inventory, including filters, hoses, sterile wipes, and other essential supplies.
  • Execute validation protocols related to injectable products, ensuring compliance with regulatory requirements.

Working Conditions and Physical Environment:

  • Requires wearing protective equipment at all times, including gloves, gowns, and masks.
  • Requires gowning qualification and simulations with culture medium (media fill) to ensure aseptic technique.
  • Work in a standing position for extended periods, with regular breaks to maintain productivity and safety.
  • Subject to environmental controls when entering aseptic areas, ensuring a sterile environment.
  • Participate in investigations following results, as required, to maintain quality and compliance.
  • Works in an aseptic environment, adhering to strict protocols and procedures.

Requirements:

  • Very good knowledge of GMPs, including regulatory requirements and industry best practices.
  • Experience in the pharmaceutical field, with a strong understanding of sterile manufacturing principles.
  • Good knowledge of regulations, including those related to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Good knowledge of sterile manufacturing principles, including aseptic technique and equipment operation.
  • Ability to work in a team environment, collaborating with colleagues and supervisors to achieve common goals.
  • Ability to withstand gowning in a controlled area at all times, maintaining aseptic technique and safety protocols.
  • Be comfortable in a highly regulated environment, adhering to strict protocols and procedures.
  • Be able to adequately complete documents according to GMP, in real-time, ensuring accuracy and compliance.
  • Good communication skills, with the ability to share knowledge during training and collaborate with colleagues.
  • Ability to concentrate and maintain focus in a fast-paced production environment.
  • Adequate physical form, with the ability to work in a standing position for extended periods.
  • Be able to work in order to reach the times established according to the quality standards in place.