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
