Global Quality Specialist

Sunrise Systems Inc.; Newark (DE); Presencial; USD 60.000 - 80.000; Jornada completa

Descripción de la vacante

Sunrise Systems Inc. is seeking a QA Specialist to support the implementation of a new batch record system. The role involves QA activities for process execution and documentation, including batch release and change control.

The ideal candidate will possess a Bachelor’s degree in a Science or technical field such as Pharmacy, Biology, Chemistry or Engineering, along with strong communication skills and a proactive learning attitude.

Formación

• Bachelor’s degree in a Science or technical field.
• Excellent oral and written communication skills.
• Strong ability and motivation to learn.

Responsabilidades

• Maintains high understanding of production processes and quality systems.
• Performs QA review and approval of GMP documentation.
• Handles change requests, batch records, and quality investigations.

Conocimientos

Excellent oral and written communication skills

Strong ability and motivation to learn

Educación

Bachelor’s degree in a Science / technical field (Pharmacy, Biology, Chemistry, Engineering)

Descripción del empleo

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

Job Description

Designation: 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.

Responsibilities

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

Qualifications

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.

Additional Information

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