Senior Specialist Quality Assurance III

Job Title: Quality Assurance Specialist – Equipment Qualification 

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Role Overview:

We are seeking an experienced Quality Assurance professional to provide end-to-end QA support for equipment qualification in a sterile pharmaceutical manufacturing environment. The role focuses on ensuring compliance during the qualification phase of a new facility producing existing vaccines. The candidate will support document review and approval, collaborate with cross-functional teams, and maintain alignment with cGMP and regulatory standards.

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Key Responsibilities:

• Provide QA oversight for the qualification of manufacturing equipment (e.g., isolators, incubators, washers, lyophilizers, fillers, formulation vessels, cappers, and inspection systems).

• Review and approve commissioning and qualification documents: URS, FAT, IQ, OQ, PQ.

• Perform pre- and post-reviews of equipment documents; ensure compliance at every qualification stage.

• Support pre-approval inspection readiness activities for new product launches.

• Review/approve GMP documentation: batch records, change controls, SOPs, risk assessments, validation protocols, and technical reports.

• Collaborate with cross-functional teams (Operations, Engineering, Validation) to ensure timely project execution.

• Ensure alignment with company Quality Management System (QMS) and current cGMP regulations.

• Independently manage QA assignments and escalate complex issues to management as needed.

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Qualifications & Skills:

• Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmacy, Chemical Engineering, or equivalent required.

• Minimum 5 years of experience in the pharmaceutical industry, preferably in sterile manufacturing environments.

• At least 3 years of experience with equipment qualification: URS, FAT, IQ, OQ, PQ for sterile manufacturing systems, facilities, and utilities.

• Strong knowledge of regulatory expectations (FDA, EU, etc.) related to sterile product manufacturing and validation.

• Proven ability to manage multiple equipment documents and support qualification milestones.

• Exceptional attention to detail, collaborative mindset, and strong communication and interpersonal skills.

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Top 3 Key Attributes:

1. Strong attention to detail

2. Proven experience in equipment qualification

3. Effective collaboration and communication skills across teams