Company: Hi-Tech Pharmacal Co.
Job Description:
Management
of quality activities within the Quality Control laboratory, specifically
focused on the technical aspects of methods and techniques. Group members will
be responsible for: Investigating and troubleshooting of Quality Control
methods. Review of QC Data for compliance to procedures and specifications
Investigations related to OOS/OOT results Participation in training of less experienced
staff on new procedures Transfer of methods from support groups to the QC
laboratory Development and authoring of complex and explicit documentation for
new and current procedures and technical reports. Laboratory studies related to
Quality Control procedures Technical guidance and resource in the QC laboratory
Oversight of the Quality Control group will include and ensure: Implementation
of new quality control procedures Transfers and development of new methods
Identifies deviations from QC methods and develops appropriate CAPAs Recommends
method improvements Contributes substantially to the interpretation of results
and subsequent impact to product/methods Implementation and monitoring of
personnel training related to new methods Represents QC as the technical
contact for laboratory projects Identifies useful resources when applicable to
meet laboratory objectives Works independently with minimal to no supervision
and direction Works in compliance with cGMPs Practices safe work habits and
adheres to safety procedures and guidelines
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