Associate Specialist, Quality Control

Job Description

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 three consecutive years (2021, 2022, 2023).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

Our Quality 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.

Job Purpose

• Support sampling / monitoring functions pertaining to facilities and utilities in the API, BIO, DPI, Tablets and R&D facilities.
• Responsible for monitoring program of facilities and utilities as required.
• Participate in facilities and utilities qualification activities as required.
• Support laboratory testing for the different drug products, semi-finished drug product and drug substances.

What you will do

• 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 and re-qualification and qualification and re-qualification of the clean rooms, when necessary.
• Provide testing support to plant validation activities
• 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 and Batch related Environmental monitoring in clean rooms and other production areas and laboratory.
• 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.
• Perform periodic review of closed out Validation Document packages and Standard Operating Procedures.
• Conduct/support investigations
• Extend documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports and any other work assigned by Senior, Lead Microbiologist, Sr/ Manager, Microbiology.
• Solicit quotations of laboratory consumables.
• Maintain continuous supply of laboratory consumables
• Participate in Safety, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Liaise with other department for training needs and technical support
• Liaise with vendor and service engineers/ESPs for equipment validation, calibration and maintenance work.
• Need to coordinate with suppliers of microbiological media and other equipment.
• Any other duties as assigned by the Supervisor / Manager.

What you should have

Qualifications

• Degree in Microbiology / Biotechnology.
• 0 to 3 years’ experience in pharmaceutical industry is preferred.
• 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.

What you can expect

• Limitless opportunities across various areas in Manufacturing; well-structured career path
• A state-of-the-art facility that delivers solution to its customers world-wide

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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