Associate Specialist, Quality Assurance (CCP for Biomedical Manufacturing Industry)

MSD INTERNATIONAL GMBH (Singapore Branch)

D22 Jurong, Jurong Island, Tuas, 50 TUAS WEST DRIVE 638408
Sgd 4,000 - 6,000 / monthly pm
On-site
Cgmp
Technical writing
Quality assurance
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 two consecutive years (2020, 2021). Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our Quality Assurance 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 WHAT YOU WILL DO: Batch Review/Batch Disposition Reviews and closes batch record Collaborates with Operations team to improve the batch record errors which includes trending analysis Performs batch disposition in SAP system and issues related batch disposition documentation Communicates to Qualified Person/Qualified Release Personnel on any information that may result in revoking of released status of any shipped material Discussion with Qualified Person/Qualified Release Personnel periodically related to batch disposition Provides Batch Review/Batch Disposition related training and serve as subject matter expert (SME) for batch review in the respective area Act as coordinator with IPT & SCM for review and release. Deviation/OOS/Customer Complaints Participates in investigations, reviews and approves investigation reports. Tracks Corrective Actions/Preventive Actions and ensures timely completion. Generates deviation summary reports. Performs trend analysis of root causes on a periodic basis. Reviews and

Job Summary

  • Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years
  • Deviation/OOS/Customer Complaints Participates in investigations, reviews and approves investigation reports
  • Tracks Corrective Actions/Preventive Actions and ensures timely completion

Matching Summary

Match Score: 75

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 two consecutive years (2020, 2021). Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our Quality Assurance 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 WHAT YOU WILL DO: Batch Review/Batch Disposition Reviews and closes batch record Collaborates with Operations team to improve the batch record errors which includes trending analysis Performs batch disposition in SAP system and issues related batch disposition documentation Communicates to Qualified Person/Qualified Release Personnel on any information that may result in revoking of released status of any shipped material Discussion with Qualified Person/Qualified Release Personnel periodically related to batch disposition Provides Batch Review/Batch Disposition related training and serve as subject matter expert (SME) for batch review in the respective area Act as coordinator with IPT & SCM for review and release. Deviation/OOS/Customer Complaints Participates in investigations, reviews and approves investigation reports. Tracks Corrective Actions/Preventive Actions and ensures timely completion. Generates deviation summary reports. Performs trend analysis of root causes on a periodic basis. Reviews and

Salary

SGD 4,000 - 6,000 / Monthly

Skills & Requirements

Must-have

  • CGMP
  • Technical Writing
  • Quality Assurance
  • CGMP Practices
  • GMP

Nice-to-have

  • Regulations
  • Complaints Procedures
  • Pharmaceutical Sciences
  • Analytical Problem Solving
  • Regulatory Requirements
  • Life Sciences
  • Pharmacy

Key Requirements

  • Minimum 2 years experience

Work Rights

Tailored Resume

Cover Letter