Global Quality Specialist

Position open with our Multinational Pharmaceutical client operating in over 100 countries.

Description:

QA Specialist - specifically supporting implementation of a new batch record system

This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs.

These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

Maintains a high level of understanding of relevant production processes and quality systems.

Performs the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:

• Change Requests
• Batch Records and associated documentation
• Product and Component Release transactions in SAP
• Quality Investigations (Deviations, Product Complaints)
• Validation Plans, Protocols and Reports
• Standard Operating Procedures

Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering.

Excellent oral and written communication skills.

Strong ability and motivation to learn.

All your information will be kept confidential according to EEO guidelines.