Total 55 Full-time microbiologist job vacancies in Singapore

JOB SUMMARY:

The Senior Microbiologist is responsible for activities on environment control, hygiene practice, sterilization and microbiological relevant matters within Quasar Medical Singapore Operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

· Maintain and comply with the requirements of ISO13485, GMP, FDA 21 CFR Part 820 and other applicable regulations.

· Participate in the internal and notified body audit programs as required.

· Management of MRR activities.

· Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality inspections,

· Ensure that non-conforming products are properly handled.

· Establishing inspection standards, plans, frequencies and test methods.

· Lead and drive QA initiatives across the product areas.

· Support and drive cost improvement project

· Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence.

· Drives robust and effective corrective and preventive action programs through the CAPA system.

· Strategically lead new product introduction from a QA perspective.

· Overall responsibility for production GMP standards and compliance, also including cleanroom requirements.

· Participate in new product introductions to ensure quality is built into all products early in their life cycle

· Support Production on all quality-related activities, including working closely with Engineering and other applicable functions.

· Assist in the investigation and analysis of customer complaints and follow-up with the relevant functions to ensure that they are addressed & closed in a timely manner.

· Assist in the definition of qualification/validation processes and the development of protocols in conjunction with appropriate functions.

· Supervision and direction of other Quality personnel.

· To support audits from customers and external regulatory agencies (FDA, BSI etc)

· Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.

SUPERVISORY RESPONSIBILITIES:

Other Quality personnel where required.

EDUCATION/ EXPERIENCE AND QUALIFICATIONS:

· Degree in Engineering or equivalent, with 3 - 5 yrs of progressive Quality responsibility, preferably in medical device manufacturing. Diploma holders in Engineering or equivalent with >5 years' relevant experience may be considered

· Excellent communication & project management skills.

· Demonstrated proficiency in use of engineering tools 6SlGMA, FMEA, DOE, SPC, etc.

· Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.

· Knowledge of ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directives.

· Proven abilities in decision making and sound personal judgement. Good organization, supervisory and investigation skills are required.

· Proven ability to influence.

WORK ENVIRONMENT:

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Controlled Environment (Class 10K/100K cleanroom) and office area.

Job Impact & Requirement

The Laboratory Technician II will complete moderately complex analytical and laboratory testing in support of the food safety quality and operational teams. In this role, you will perform routine analysis of product testing and will check and monitor instrumentation performance, conduct tests and document results into databases and communicate test results.

Key Accountabilities

• Conduct routine quantitative and qualitative inspections and laboratory tests on raw materials, in process and final products independently and support more complex trials and experiments under intermediate supervision.
• Perform Environmental Monitoring - in-line swabbing, ATP swabbing and lab analysis
• Prepare medium and apparatus for microbiological analysis (environmental monitoring)
• Prepare samples and coordinate with 3rd Party Laboratory on the external microbiological laboratory testing for FGs, RMs, swab samples and as per customers’ requirements.
• Ensure compliance programs for all individual testing, which includes monitoring adherence to regulations and other procedural food safety compliance.
• Interpret and document results of tests into active databases and communicate results to internal customers as required.
• Run calibration checks, preventive maintenance tasks and simple repair to analytical instrumentation and maintain customer specifications books.
• Help develop food and feed safety, quality and regulatory culture and collaborate cross functionally to build, maintain and improve an effective food safety, quality and regulatory culture.
• Handle moderately complex clerical, administrative, technical or customer support issues under general supervision, while escalating more complex issues to appropriate staff.
• Other duties as assigned

Minimum Qualifications

• Possess technical and analytical skills in Quality Control
• Demonstrate analytical thinking and problem solving skills
• Possess a good sensory skills for product evaluation and troubleshooting
• Demonstrate ability to handle work professionally, independently and efficiently
• Possess attention to details

We are seeking for a QC Specialist to join our team to support our client in Pharceutical Industry. This is a contract role for a year subject to extention as per client's need.

Responsibilities:

• Perform microbiological analysis of raw material, GPT, ID samples according to Standard operating procedures and Test Methods
• Perform EM which includes BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases /air and water / clean steam sampling in accordance to cGMP procedures when required
• Documentation of results in accordance with cGMP
• Prepare EM trend reports, EM reports for product lot release and trend reports
• Review routine data and logbooks with supervisory audit
• General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
• Problem solving of issues as well as troubleshooting of equipment
• Author or update existing SOPs, Forms and TMs as needed
• Discrepancy Owner or perform assessment of lab related discrepancies
• Involve in new equipment / methods qualification
• Participate internal and external audits and regulatory inspections
• Understanding of basic microbiological principles (bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET)
• Perform equipment qualification / maintenance, liaise with external / contract lab / vendor
• Lead the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs
• Comply with all client's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements
• A team player and the willingness to cover other colleagues in continued support of the Micro/EM testing operations.

Requirements:

• Bachelor's Degree (Chemistry, Microbiology, Biochemistry or any Life Science related is preferred)
• Minimum 1 to 3 years' work experience in the pharmaceutical or related industry preferably QC related
• Knowledge of cGMP relevant to the pharmaceutical industry
• Able to determine when to escalate issue
• Ability to organize and plan effectively
• Good team player
• Demonstrate good verbal and written communication skills in English
• Must be comfortable with contract basis role

Key Responsibilities:

• Assist to manage / supervise the work of subordinate staff to provide microbiological and biological testing services to ensure successful performance and timely delivery of the study results
• Develop and validate new test methodologies
• Review test data and prepare test reports
• Handle enquiries and quotation as well as interface with customers on sample submissions, job status, technical matters
• Ensure compliance with laboratory quality management (ISO 17025, OECD GLP and GMP) and safety guidelines
• Ensure staff competency for the testing services
• Review and develop SOP
• Perform CAPA for non-conformance in laboratory
• Oversee the proper upkeep and maintenance of test equipment and instruments

Key Requirements:

• Minimum a Degree in Microbiology, Biological Sciences or related disciplines
• Preferably 3-5 years of work experience in Microbiological Testing laboratories
• Familiarity with ISO 17025 quality management system and OECD GLP & GMP quality system would be advantageous
• Results and service-oriented individual who possesses initiative and good communication skills
• A proactive team player but with the ability to work independently in challenging projects and timelines
• Enthusiastic and resourceful with a "can-do" attitude

Essential Duties and Responsibilities:

• To demonstrate and promote the company vision
• To have regular attendance and observe punctuality
• To apply GMP/GLP in all areas of responsibility, as appropriate
• To conduct routine microbiological analyses in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines in a timely manner
• To ensure all quality control procedures are in place along with identifying and reporting any quality issues
• To observe good documentation practices in all laboratory records
• To use all laboratory equipment and software appropriately and safely for assigned tasks
• To be effective in planning assigned workload on a daily basis
• To work cohesively in a team environment. Plans individual workload in coordination with team members
• To maintain a clean and safe laboratory work environment
• To conduct all laboratory activities in a safe and efficient manner
• To complete all required training courses
• To perform other duties as assigned.