Associate Specialist, Quality
4 weeks ago
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,
· 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.
The role will be responsible for planning, scheduling and performing laboratory testing of raw materials, packaging components, excipients, in-process control samples, intermediates, semi-finished products, final drug substances and finished products manufactured in the manufacturing facilities.
What will you do
Critical responsibilities but not limited to:
- Responsible for ensuring the analytical methods / specifications used are in accordance with requirements specified in our company Quality Standards, regulatory dossiers and pharmacopoeia.
- Manage the calibration, maintenance and qualification of laboratory equipment.
- Conduct laboratory investigation on laboratory equipment failure, OOT and OOS.
- Responsible for testing of developmental and clinical products as required.
- Participate in analytical developmental activities as required
- Perform analytical testing on incoming raw materials, packaging components and excipients.
- Carry out testing activities associated with release and stability testing of the in-process control samples, intermediates, semi-finished products, final drug substances & finished products.
- Ensure tests assigned are performed in a timely manner in compliance to Standard Operating procedures with necessary laboratory safety precautions.
- Carry out cleaning sample testing related to any equipment or facility cleaning activities.
What you must have
To be successful in this role, you will have:
- Degree holder in Chemistry, Biochemistry or equivalent field.
- Candidate with relevant GMP / Pharmaceutical lab experience such as chromatographic analysis (HPLC/GC) and Empower software are preferred.
- Able to work under stress, in a fast pace environment with high level of 'right-first-time' and high integrity in lab testing and reviewing.
- Detail orientated, organized, neat in his/her work, good planning ability & high efficiency.
- Good leadership skills, excellent working attitude and able to work well in teams.
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 HERE
Current Contingent Workers apply HERE
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.
Employee Status:
Temporary (Fixed Term)Relocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/20/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:09/20/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R309374
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