南京招聘

Business Segment

Healthcare Quality

Role Summary/Purpose

Description: The Laboratory Specialist will be responsible for performing and reporting of routine analytical tests according to the specifications; drafting/revising/reviewing SOPs, methods, specifications, training modules and IQ/OQ protocol; translating methods; training new specialists and following up on the corresponding specialist’s work in the Laboratory.

Essential Responsibilities

• Participate in new, corporate and local projects and take part in the validation work throughout the plant, in which Laboratory resources are required.

• Be responsible for the sampling and testing of utilities/raw materials, in-process samples, semi-finished/finished products, and primary packaging materials as well according to designated task.

• Responsible for the import analysis application with the appropriate authority of all import drugs including API and semi-finished/finished products in compliance with regulatory authorities as appropriate in the host country.

• Regulatory Requirement for analysis issues.

• Ensure that all the raw data during the testing are correctly recorded down and all results or testing investigation summary are made completely and timely.

• Ensure that corporate and local EHS procedures are followed.

• Responsible for the instrument/equipment management in Laboratory, i.e. ensure that each individual instrument/equipment archive be maintained properly with integrated life-cycle documents; update Laboratory instrument/equipment Calibration Matrix whenever necessary; scheduling monthly calibration and according to Laboratory instrument/equipment Calibration Matrix; ensure that all instrument/equipment Calibration in Laboratory are executed adhering to the schedule; approve Laboratory Calibration Sheet and calibration results; follow-up and ensure the implementation of instrument/equipment IQ/OQ/PQ.

• Notice: Before taking any responsibility, specialist shall be trained and have relevant qualification first.

• Be able to finish the tasks arranged and required by Lab Manager or Supervisor.

Qualifications/Requirements

Quality Specific Goals:

1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

2. Complete all planned Quality & Compliance training within the defined deadlines

3. Identify and report any quality or compliance concerns and take immediate corrective action as required.

4. Knowledge and understanding of document control, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements.

1. Bachelors degree in Life Sciences, Chemistry, Physics, Biomedical Engineering or related field and 2 years relevant work experience or High School degree and 6 years relevant work experience

2. A good knowledge of computer and English

Desired Qualifications:

1.Experience from pharmaceutical quality control laboratories and basic knowledge of GMP is desirable.

2. Knowledge of lab instruments is desirable.

Desired Characteristics

N/A

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