PGS-Wuxi-生产部-操作员Ⅱ

Use Your Power for Purpose

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer's mission. You will help to ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated, as it directly influences the availability of essential medications. Your dedication and agility are crucial in maintaining the high standards of our manufacturing processes. By continuously striving for excellence, you contribute to the overall mission of delivering life-saving treatments to those in need. Your commitment to improving outcomes ensures that our breakthroughs reach the patients who depend on them.

What You Will Achieve

• 1. Production Operations Complete product production according to relevant Standard Operating Procedures (SOPs) and batch production record requirements. Fill in job logs, batch records, and other documentations in compliance with data integrity (DI) requirements.
• 2. Product Quality Control Comply with Good Manufacturing Practices (GMP) for pharmaceuticals and Pfizer Headquarters Quality Standards (PQS). All operations should follow SOPs to ensure the quality of the product.
• 3. Equipment Maintenance and Management Carry out effective daily cleaning, maintenance, and operation of production equipment to ensure its proper functioning and use within the calibration validity period.
• 4. Safety and Hygiene Ensure safe production operations, maintain cleanliness and hygiene at the production site, comply with national and company regulations, and follow relevant management measures
• 5. New Products, New Equipment, and New Processes Participate in trial production of new products and commissioning of new equipment to ensure smooth implementation of new products, new equipment, and new processes.
• 6. Team Spirit Work together with other employees to achieve team goals, carry out handovers diligently, and report deviations in a timely manner.
• 7. Employee Discipline Abide by relevant employee codes of conduct and follow work arrangements.
• 8. Comply with company Environment, Health, and Safety (EHS) policies and regulations, and complete related EHS tasks.
• 9. Ensure actions comply with national laws, regulations, and policies.
• 10. Assist production managers in training new employees on their positions.
• 11. Assist in daily validation tasks and the implementation of new validation projects.
• 12. Provide suggestions for the review and revision of relevant production documents and SOPs.
• 13. Complete other tasks assigned by supervisors.

Here Is What You Need (Minimum Requirements)

• 1. Education/Experience:
  •
• Secondary vocational school with 2-4 years of pharmaceutical production operation experience, or junior college with less than 2 years of pharmaceutical production operation experience.
• 2. Special Knowledge:
• GMP knowledge in the pharmaceutical industry
• Basic microbiology knowledge
• Personal hygiene behavior standards
• Cleanroom gowning behavior standards
• Aseptic and cleanroom operation standards
• Basic knowledge of environmental monitoring and personnel inspection
• Knowledge of disinfection and sterilization procedures
• Basic knowledge of English and computers
• Other national pharmaceutical regulations, labor law, environmental protection law, etc.
• 3. Skills:
• Gowning in clean areas
• Operations in clean areas and aseptic pharmaceutical operations
• Proficient operation of production equipment
• Storage and use of sterilized materials
• Cleanroom hygiene operations
• Material entry into clean areas
• Coordination, communication, analytical judgment, and teamwork abilities
• Basic oral and written communication skills

Bonus Points If You Have (Preferred Requirements)

• A Bachelor's Degree
• Experience with Lean Manufacturing principles
• Knowledge of regulatory requirements and quality standards
• Familiarity with Pfizer's Learning Solution and Quality Tracking System
• Ability to adapt to changing priorities and manage multiple tasks
• Ability to train and mentor less-experienced colleagues

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.