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Job Responsibility
-Conducts Quality Assurance in-process checks of experiment carried out by technician in laboratory as directed by appropriate Standard Operating Procedures. In-process checks include but not limit to:
-ensuring properly calibrated/ validated equipment used;
-ensuring personnel performing evaluations in the laboratory is trained & qualified
-reviewing of laboratory note book, label and equipment log- books etc. to ensure all testing appropriately documented
-Issues Laboratory Notebooks and Equipment Log Books, and maintains lot numbering database.
-Be Responsible to distribution, return and update of controlled documents, such as testing method and SOPs;
-Maintains electronic version of SOPs;
-Drafts new SOP and transfer GSOPs to local SOPs;
-Archives all quality records each year, including OOS, CAPA, Deviation, equipment calibration record and so on.
-Follows up Deviation, OOS and CAPA log-in and close-out;
-Supports ISO 17025 inspection and client audits;
-Supports Quality Management Systems such as the Deviation Reporting, CAPA, Document Control and OOS Programs. Also, assists in laboratory investigations of unexpected results and performs internal and external quality audits.
-Maintains annual equipment calibration and preventive maintenance plan.
-Liaises external calibration, informs related lab for internal calibration, and updates calibration information timely;
-Approves equipment internal calibration reports;
-Supports equipment qualification and preventive maintenance
-Carries out SOPs training to new staff

Job Requirements:
-Bachelor's degree with 3 years above relevant experience in a pharmaceutical type industry.
-Good understanding of GMP or GLP and ISO17025 regulations and integration of regulations into working system in the laboratory
-Good English and communication skill and can work under pressure
-Capable of handling external audit independently

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Welcome to join SGS!
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sgshr

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Originally posted by zhangwei19 at 2011-07-21 16:13:06:

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