Senior Qc Microbiologist

2 weeks ago

Singapore GDMC Full time

**Key **Responsibilities**

Your responsibilities include, but are not limited to:

- This position will support operational readiness of a new facility.
- Establishment of QC procedures (drafting and reviewing QC functional SOPs including QC testing SOPs).
- Responsible for Environmental monitoring (Viable and Non-Viable) of Cleanrooms, water and gases as per SOPs.
- Responsible for the Microbiological Testing of Water/Raw Material/in-process/ finished product / stability/validation/utility samples as per approved SOPs.
- Perform GPT, Sterility Testing & Microbial Identification.
- Support Sample Management functions.
- Ensure testing support media and consumable inventory timely manner to avoid delay in testing.
- Write, review and update standard operating procedures timely manner to operate EM and Microbiology operations and to ensure that specifications are in compliance with current GMP requirements/standards.
- Maintain data integrity and appropriate traceability.
- Responsible to identify OOS/OOT/Deviation and participate in Root Cause Analysis (RCA) and recommend corrective and preventive actions as applicable.
- General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc. Responsible for microbiology lab and equipment/ instrument cleanliness.
- Responsible for disposition of samples upon confirmation.
- Collaborate with other functional teams in new processes/equipment/method qualifications.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

**Required Skills/Experiences**
- Ability to prioritise work and multitask.
- Thorough knowledge and understanding of current regulatory requirements of GMP Biologics and Pharmaceutical industries,
- Understanding of EudraLex Cleanroom Grades and ISO14644-1:2015 Cleanroom classifications
- Good knowledge and understanding of Biologics manufacturing, aseptic operations and cleanroom behaviour.
- A demonstrated ability to supervise, train, and manage technical staff.
- Demonstrated knowledge in Quality Control operations as it relates to method validations and QC system implementation is an added advantage, cGMP regulations and audit experience in USFDA, EU and HSA etc.

**Additional Skills/Experience**
- Must be able to work in Singapore.
- Excellent communication, interpersonal and organisational skills.
- Ability to speak and write in English.

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