Primary Function

Provide technical and professional expertise to the QC microbiological laboratory, supporting manufacturing / customer supply, quality and regulatory aspects of the business.

Primary Accountabilities/Responsibilities

• Lead analytical investigations within the QC micro lab, ensuring that customer supply and quality is maintained at all times.
• Perform routine analytical testing and/or Second Person data verification (2PV) and/or Test Result Release (TRR) if required by the business.
• Oversight of method validation and routine testing of products and excipients in accordance with USP/EP requirements. In particular, microbial enumeration and absence of specified microorganism testing in accordance with EP chapter 2.6.12 & 2.6.13 and USP chapters <61> and <62>.
• Oversight of the microbiological testing of purified water plus other water grades.
• Experience in the identification of microorganisms, media preparation (including growth promotion testing), microbial culture preparation and maintenance and the use of autoclaves.
• Understanding of potentially objectionable microorganisms and ability to generate microbiological risk assessments as required.
• Oversight of the environmental monitoring program including viable (microbial) and non-viable (particulate) monitoring and responding to environmental monitoring excursions.
• Responsibility for performing an annual review of the environmental monitoring data and implementation of alert & action limits as well as assessment of the normal microbial flora of the area.
• Assist quality leadership team in attaining a culture of world-class customer service, world-class quality, continuous improvement and a commitment to excellence within the department, the site and the company.

• University degree in Microbiology
• At least 10 years of experience in execution of microbiological testing in pharmaceutical field.
• Good English (oral and written) required
• Familiar with MS Excel and word.
• Communication skills
• Knowledge of cGMPs, working knowledge of safety.

Other Information

1. Travel: N/A

2. Location: 五四工厂，上海市奉贤区五四农场场中路1号.

上班地址：上海市奉贤区五四农场场中路1号