Quality Assurance Specialist

Quality Assurance is responsible for gathering and collating data from the various departments of the Pharma manufacturing site and preparing for batch approval by the Qualified Person (QP).

Key Responsibilities of the Quality Assurance Specialist

The position is responsible for carrying out tasks and projects related to managing QA activities related to the site as required by GMP. These activities include change control, nonconformance investigation, raw material and batch release, quality systems auditing, and validation review activities .

Role/Opportunity:

• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.Supports the development and management of GMP QA systems
• Develop and implement processes, procedures, forms, work instructions and tools related to the implementation of quality systems at the site.
• Assesses QA systems on ongoing basis to identify opportunities for process improvement.
• Reviews and/or approves nonconformance investigations and their associated documentation.
• Carries out tasks related to the management of project and site change control systems
• Review and approval of qualification/validation documentation.
• Carries out administration of the Supplier Assessment, Auditing and Inspection Readiness Systems at the site
• Reviews and approves SOPs/work instructions/forms/validation plans from other departments on behalf of Quality Assurance.
• Support QA activities for new product introductions

Skills/Experience

• BSc essential
• A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Experience in development/and or evolution of GMP systems is desirable