Sterile Form Production Technician
2 weeks ago
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 ensure 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).
- 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 adhering to protocols.
- Be comfortable in a highly regulated environment, with a strong attention to detail and commitment to quality.
- 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 environment, with multiple tasks and deadlines.
- Adequate physical form, with the ability to work in a standing position for extended periods and perform tasks that require manual dexterity and attention to detail.
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