Senior QA Specialist | 3 shifts | BREDA

? Important: This is a rotating 3-shift position. Full commitment to the shift pattern is required.

Shift Structure (Rotating Weekly):

• Week 1: Night shift (22:30 – 07:00)

• Week 2: Late shift (14:30 – 23:00)

• Week 3: Early shift (06:30 – 15:00)

• Week 4: Late shift

• Week 5: Early shift

Purpose of the Role

The Senior Associate QA provides on-the-floor Quality Assurance support within the ABR production environment, ensuring GMP compliance across packaging and labeling operations. The role acts as a key QA representative in production, supporting batch record review, deviation management, and compliance oversight, while building strong cross-functional relationships with Production, Warehouse, Maintenance, Engineering, QA Management, and the Qualified Person (QP).

Responsibilities

• Provide daily QA guidance and support to Production teams regarding GMP compliance, SOPs, and Work Instructions.

• Act as first point of contact for quality-related queries during packaging and labeling operations.

• Review and approve batch production record entries prior to execution.

• Perform in-process and finished product checks during commercial production runs.

• Compile and review batch records in preparation for QP disposition.

• Conduct GMP compliance checks within the production area.

• Review, approve, initiate, and own deviation records as required.

• Support and participate in investigations related to quality events.

• Author and review operational SOPs and Work Instructions as needed.

• Support development and delivery of GMP training for QA and Production staff.

• Contribute to QA-related production projects and continuous improvement initiatives.

• Prepare weekly/monthly QA metrics and maintain departmental performance boards.

• Ensure data integrity by identifying, categorizing, evaluating, and resolving issues.

Requirements

Essential (Must-Have)

• MBO or BSc degree in Pharmaceutical Sciences, Life Sciences, or related field (or equivalent combination of education and experience).

• Minimum 3 years of QA or manufacturing experience within pharmaceutical or medical device environments.

• Hands-on experience with batch record review and deviation investigations.

• Strong knowledge of GMP (GDP/GCP knowledge is a plus) with ability to interpret and apply regulations in a production setting.

• Experience within manufacturing and/or quality analytical processes.

• Ability to work under pressure in a fast-paced production environment.

• Strong communication skills and ability to act as mediator between QA and Production.

• Fluent in English.

• Full availability and commitment to a rotating 3-shift structure.

Desired (Nice-to-Have)

• Experience in packaging and labeling operations.

• Experience working in commercial manufacturing environments.

• Exposure to QA production support roles in highly regulated environments.

• Experience supporting cross-functional improvement projects.