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
