Job Summary

In this role, you will manage the YBB laboratory operation, lead, develop the YBB laboratory team and contribute to the global laboratory initiatives and activities.

Essential Duties and Responsibilities

• Perform and oversee routine and non-routine testing of finished products according to respective test procedures, compendia methods and YBB standards.
• 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 Chemical test equipment/ methods whenever required.
• Perform test method validation/ inter-lab round robins, and act as subject matter expert or liaison with other sites.
• Provide technical support in the form of Chemical investigations of test method, product, facilities, critical systems to facilitate timely resolution of OOS, deviations, non-conformances, specification review, etc.
• Represent Chemical laboratory as regulatory/ customer auditee and perform audits from Chemical aspects.
• Write/ review/ implement procedures/ protocols/ studies relating to YBB standards.
• Recruit and ensure proper training of all YBB laboratory staff.
• 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

Education

• Bachelor’s degree in chemistry or equivalent

Work Experience

• Minimum of 10 years’ experience in a pharmaceutical or chemical 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 chemical environment or equivalent
• Proficiency in English language (speak/ read/ write)