QA Specialist

Job Overview

QA Specialist provides oversight of GMP operations to ensure that products are manufactured according to cGMP requirements and fit for their intended use. Maintains data collected from the manufacturing process, generates, and updates procedures and ensures Batch Records comply with established policies and procedures.

Main Responsibilities

• Review and Approve Production Batch Records and Testing Results to ensure they are complete, accurate and documented according to established procedures.
• Prepare CofC and CoAs.
• Maintains QA manufacturing floor presence in support of manufacturing operations and provides oversight over process related decisions.
• Reviews and approves Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions and Test Methods.
• Provides oversight to Risk Management programs, procedures, and documentation for Development and Process Validation activities.
• Review and approve Test Method Development, Validation, and Transfer activities in support of the Analytical Sciences department.
• Review and approve Stability Studies protocols and reports.
• Supports the investigation process for Non-Conformances and ensures completion of related corrective and preventive actions.
• Supports the Audit Team with during external and internal audits.
• Provides support to the program management office with the review and approval of the design transfer package documentation.
• Provides Quality support for throughout the product lifecycle to include the review of Annual product reviews, Product Process Monitoring activities and Continuous Improvement initiatives.

Skills and Qualification

• Preferred BS in Engineering, Biology, or other technical related degree
• A minimum of 4 years of experience in Quality with Pharmaceutical and/or Medical Device based GMP manufacturing operations.
• Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
• Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations.
• Knowledge of regulations and practices pertaining to pharmaceutical/medical device products in area of responsibility.
• Ability to interact with regulatory agencies. knowledge of FDA, EMA, JP and other regulations.
• Knowledge of Good Manufacturing Practices & Good Documentation Practices
• Able to communicate effectively and work within cross-functional teams.
• Excellent oral and written communication skills with strong technical writing experience required.
• Experience in internal / external audits, identify findings, drive resolution, and provide closure report
• Proficient skills in solving complex problems and ability to bring issues to resolution.
• Experience working globally with diverse teams and cultures

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Variety of opportunities for personal and professional development within a global organization

How we hire

Once you’ve applied, it may take up to three weeks to review your application and get the first call with a recruiter. Our recruitment process is focused on allowing you to show your personality, experience and competencies while giving you a great sense of who we are.

Grounded in belonging, we strive for excellence. With almost 6,000 employees of 77+ different nationalities, we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth. Together, we invest in our future to maintain our leadership position in drug delivery systems.