Senior Quality Assurance Specialist

Your Responsibilities:

• Act as the primary point of contact for QA-related topics for both customers and internal stakeholders.
  
  
• Provide routine updates to customers on QA-relevant topics
• Coordinate and deliver product-specific documents in a timely manner
• Coordinate and present quality reviews to internal stakeholders and customers as required.
  
  
• Lead investigations for customer complaints and ensure records are closed in accordance with customer requirements and internal SOPs.
• Provide QA oversight in customer project-related activities, including review and approval of batch records and/or CAPA outside of routine operations, ensuring accuracy, timely delivery, and compliance with quality requirements.
  
  
• Provide QA Operations oversight to site improvement projects
• Attend and contribute constructively in internal and external customer project meetings.
  
  
• Participate in and/or lead resolution of complex process or project issues.
  
  
• Coach and indirect management of junior members of the QA team.
  
  
• Formulate and articulate solutions to issues/problems for internal/external teams and management.
  
  
• Represent QA Operations in cross-functional decision-making meetings (internal and external).
  
  
• Maintain Site Master Validation plan, set objectives and ensure process validations performed to meet regulatory requirements.
  
  
• Lead and Conduct internal audits, drive actions to implement CAPA.
  
  
• Implement and maintain change control process for the site.
  
  
• Any other duties as assigned by your Supervisor/Manager.
  
  

Your Profile:

• Degree/Diploma in Life Sciences, Biotechnology, Chemistry, or related discipline.
  
  
• Relevant QA experience in the pharmaceutical, biotech, or related life sciences industry.
  
  
• Strong understanding of cGMP requirements and QA processes.
  
  
• Proven ability to manage customer interactions and deliver quality documentation in a timely manner.
  
  
• Knowledge or experience in food safety requirements
• Prior work experience in implementation and maintenance of ISO22000, FSSC22000, BRC or relevant certification is advantageous
• Proficient in written and spoken English
• Computer-literate with knowledge of MS Office applications
• Knowledge of Microsoft Dynamics is a plus
• Possess good self-discipline
• A good team player with strong initiative and an analytical mind