
Associate Manager, Microbiology
2 weeks ago
Job Summary:
In this role, you will manage the Singapore Microbiology laboratory operations, lead, develop the Microbiology laboratory team and contribute to the global laboratory initiatives and activities.
Essential Duties and Responsibilities:
- Perform and oversee routine and non-routine Microbiological tests of products, water systems and cleanrooms.
- Ensure adequacy of laboratory support systems such as equipment, consumables, peripherals, sterilization, reagent preparation, accessories and manpower.
- Develop and implement the local laboratory strategy (laboratory resource, laboratory budget and Capex plan) in accordance with the global site lab strategy and local site strategy, based on local and global sample volume demand forecast.
- Set up Microbiological/ Particulate test equipment/ methods whenever required.
- Provide technical support in the form of Microbiological investigations of test methods, products, facilities, critical systems to facilitate timely resolution of OOS, deviations, non-conformances, specification review, etc.
- Perform test method validation/ inter-lab round robins, and act as subject matter expert or liaison with other sites.
- Represent Microbiology laboratory as regulatory/ customer auditee and perform audits from Microbiology aspects.
- Perform environmental monitoring date trending of facilities and water systems.
- Write/ review/ implement procedures/ protocols/ studies relating to Microbiological tests.
- Recruit and ensure proper training of all Microbiological laboratory staff.
- Build up the Microbiological testing capacity in Singapore Laboratory and support the West network to perform Microbiological testing.
- Participate and support the locate site management and global lab activities.
- Drive continuous improvement for laboratory processes with regards to efficiency, compliance, and safety.
- Quality: The job holder is aware of his/ her special responsibility for quality and conducts his/ her activities in accordance with the Company quality policy at all times by (i) ensuring Good Manufacturing/ Laboratory Practices are in place, (ii) ensuring all documents used are up-to-date and proper records are kept, (iii) ensuring compliance to GMP requirements for the laboratory, (iv) advancing best practices in Data Integrity.
- SOP: The job holder is aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
- Safety: The job holder is aware of his/ her special responsibility towards health and safety in accordance with the company's safety policy at all times by (i) ensuring safety rules are adhered to at all times, (ii) ensuring personnel in the laboratory don the appropriate Personal Protective Equipment (PPE).
- Lean: Support and contribute actively to the Lean Sigma Programs and activities towards delivery of the set target by (i) leading in lean initiatives in the laboratory, (ii) supporting lean initiatives in the plant.
- Any other relevant duties as assigned by the Laboratory Manager.
Basic Qualifications:
- Bachelor's degree in Microbiology or equivalent
- Minimum of 10 years' experience in a pharmaceutical or biomedical industry or equivalent
Preferred Knowledge, Skills and Abilities:
- Familiarity with cGMP and GLP
- Strong leadership qualities
- Effective communication and interpersonal skills
- Laboratory management experience in a pharmaceutical or biomedical industry or equivalent
- Proficiency in English language (speak/ read/ write)
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