
Instrument Manager
1 week ago
Job Title: Instrument Specialist
We are seeking a skilled professional to manage our analytical instruments and ensure their efficient operation.
- Select, purchase, install, commission, validate, calibrate, maintain, and repair laboratory instruments
- Draft procedures and technical documents related to instruments and participate in process optimization
- Conduct events and investigations related to instrument management
- Initiate changes and track execution of corrective actions
- Assist analysts in troubleshooting and provide training on relevant skills
- Evaluate data integrity of instrument systems and improve departmental data integrity
- Study regulatory documents and update internal procedures
- Participate in audits and inspections, address issues, and ensure compliance with regulations
- Track work progress, communicate with stakeholders, and establish relationships
Required Skills:
- Bachelor's degree in a relevant field, such as pharmacy or chemistry
- Understanding of pharmaceutical production, testing, and quality management; familiarity with regulatory requirements
- Proficient in English and Chinese, fluent in spoken English and Chinese for communication with stakeholders
- Good computer skills and experience with analytical software
- Over 3 years of experience in analytical instrument management, with regulatory experience given priority
- Proficiency in analytical testing and quality management, familiarity with instrument structure and working principles
- Familiarity with industry laws and regulations regarding technical specifications for analytical instruments
- Familiarity with industry requirements for data integrity of analytical software
- Strong problem-solving, coordination, communication, and execution skills
- Detail-oriented, proactive, and able to work under pressure
- Ability to determine problems, gather information, understand facts, and draw effective conclusions through scientific reasoning
- Project management and tracking skills
Key Responsibilities:
- Instrument Management: Select, purchase, install, commission, validate, calibrate, maintain, and repair laboratory instruments
- Procedure Drafting: Draft procedures and technical documents related to instruments and participate in process optimization
- Event Conduct: Conduct events and investigations related to instrument management
- Change Initiation: Initiate changes and track execution of corrective actions
- Troubleshooting Support: Assist analysts in troubleshooting and provide training on relevant skills
- Data Integrity: Evaluate data integrity of instrument systems and improve departmental data integrity
- Regulatory Compliance: Study regulatory documents and update internal procedures
- Audit Participation: Participate in audits and inspections, address issues, and ensure compliance with regulations
- Relationship Building: Track work progress, communicate with stakeholders, and establish relationships
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