Job Descriptions

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the QA Specialist role will make an impact:

• Ensure all product is manufactured, tested, and released in compliance with ICHQ7a and Viatris requirements by:
  • Review and approval of master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing
  • Disposition of intermediates and API
  • Review and approval of deviations, change controls, SOPs, out of compliances, lab investigations and cleaning batch records.
• Lead internal audits and reviews of manufacturing operations and quality systems to ensure compliance with cGMPs and other regulatory requirements.
• Assist with regulatory inspections.
• Assist with the development and delivery of cGMP training.
• Assure site compliance with CGMPs and Corporate Policies/Procedures.
• Provide Quality Assurance Support for Validation.
• Maintain knowledge of regulatory environment, ICH, cGMPS, FDA and EMA.
• Provide technical expertise to colleagues regarding the interpretation and/or implementation of cGMP matters.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor of Science Degree in Pharmacy, Chemistry, Chemical Engineering or another related field.
• 3+ years of experience in pharmaceutical manufacturing product development, quality control and/or cGMP compliance.
• Experience in collaborative working and problem solving.
• Strong technical, analytical, and problem-solving skills with the ability to make timely decisions.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Skills

• Communication Skills
• Analytical Skills
• Problem Solving Skills

Experience

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