Specialist, Quality Change Control & Stability - One Year Contract

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.

WHAT YOU WILL DO

Reporting to Senior Manager, Quality Control, you will be responsible for, but are not limited to:

1) Provide change control oversight for Supplier, Manufacturing, Engineering, Warehouse, Incoming Laboratories and Finished Product Laboratories in Pharm or API plants.

2) Provide Quality Operation related impact assessments for change controls. 3) Review and approve supplier, manufacturing, warehouse, facilities, utilities and analytical change controls.

4) Plan, material control for the incoming material and final product release which are impacted by change controls.

5) Review and approve validation protocols, reports and other validation related documents for manufacturing equipment’s, HVAC & utility systems, lab chambers.

6) Review and approve validation documents in compliance with validation requirements.

7) Partner with other site QA and change owner / project lead to complete the change control/project on time.

8) Support site management in continuous improvement efforts in streamlining change control practices for efficiency, consistency and compliance, e.g. Accelerate or Hoshin.

9) As a subject matter expert, be able to respond to enquiries related to QA and projects and approaches during internal and external audits and inspections, and work on audit responses and follow-up actions as needed.

10) Any other duties assigned by the manager.

WHAT YOU SHOULD HAVE

To be successful in this role, you should have good knowledge on cGMP, GDP and Quality Assurance and change control. Be passionate about teamwork and knowledge sharing, and proactive on continuous improvement. Other pre-requisites and attributes include:

1) Possess a Bachelor’s degree in Chemistry/Chemical Engineering or related Sciences, with a minimum of 3 years of experience in QA position in pharmaceutical or related industry.

2) Good knowledge and understanding of GMP and data integrity requirements. Good coaching, communication and interpersonal skills.

3) Demonstrate the ability to actively seek opportunities to continuously improve and simplify processes and procedures.

Other Personal Attributes:

• Self-motivated
• Independent
• Team Player
• Highly Approachable

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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