Microbiologist - One Year Contract

1 week ago

Singapore MSD Full time

**THE OPPORTUNITY**
- ** Be part of the team that ensures sustainable products meets standard quality and committed to deliver to customers worldwide**:

- ** Based in Singapore**, the regional hub for **Asia Pacific (AP) **and **top-ranked biopharmaceutical company on the Straits Times **and** Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).**:

- Join the** premier biopharmaceutical company** that has been **in Singapore for more than 25 years and in AP for over 60 years.**

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**What will you do**

**Description**
- Support testing/ monitoring functions pertaining to aseptic manufacturing and microbiological testing of Raw materials, Excipient, In-process materials, semi finished and finished products manufactured in the facilities.
- Responsible for testing of developmental and clinical products as required.
- Participate in analytical developmental activities as required.

**Main Responsibilities**:

- Perform in-process and release samples testing of excipient/ packaging components for the different drug products, semi finished drug product and drug substances. i.e., Bioburden test, Microbial Limits Test, etc., as appropriate.
- Perform routine/non-routine quality monitoring, sampling and testing of Utility systems inclusive of Purified water, Water for Injection, Pure steam. Compressed air and Nitrogen systems.
- Perform the routine/non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring test.
- Perform personnel qualification/re-qualification, and qualification/re-qualification of the cleanrooms, when necessary.
- Perform routine and Batch related Environmental monitoring in clean rooms and other production areas and laboratory.
- Provide testing support to plant validation activities
- Perform Media Receival, Sterility check and Growth Promotion Tests for media used for testing.
- Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures.
- Perform microbial identification (Bacteria, mold and yeast) in water, environment and product samples.
- Ensure that tasks as assigned are performed in a timely manner in accordance with standard operating procedures (SOPs) and current GMPs and GLP with necessary safety precaution.
- Maintain complete and accurate recording of all testing performed in the relevant logbooks and worksheet.
- Report any anomaly (e.g. Out of specifications, Out of alert and atypical events) encountered during the sampling/testing and calibration/verification of laboratory equipment.
- Perform periodic review of closed out Validation Document packages and Standard Operating Procedures.
- Extend documentation support to the department by participating in writing/revising of SOPs, protocols, test reports and any other work assigned by the Senior, Lead Microbiologist, Manager.
- Liaise with external vendors and service engineers for instrument calibration and maintenance, equipment validation, calibration and maintenance work.
- Maintain continuous supply of laboratory consumables and media, coordinate with suppliers of consumables, media and equipment
- Liaise with other department for training needs and technical support
- Participate in Safety, Business Compliance, cGMP and all other compliance-related matters, where applicable.
- Assist in maintaining good housekeeping of the work areas and laboratories.
- Conducts work in accordance with Company EHS procedures, guidelines and expectations and demonstrate best EHS practice.
- Maintains positive working relationships among employees and fosters an environment where employee engagement, empowerment, teamwork and accountability are the cultural norm
- Any other duties as assigned by the Supervisor / Manager.

**What you must have**

**Qualifications**
- Degree in Microbiology / Biotechnology
- 0 to 6 years’ experience in pharmaceutical industry is preferred

**Required Skills / Experience / Competencies**:

- Previous OJT is preferred
- Good understanding of Safety and cGMP practices
- Computer Literacy
- Experience in operating laboratory equipment and lab computer systems is very desirable
- Good oral and written communication skills

**Job requirements**
- Desire to work in rotational shifts, supportive of shift-work when requested by management - business continuity

**WHAT YOU CAN EXPECT**
- Limitless opportunities across various areas in

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