Senior QA Specialist

About the role

The Senior QA Specialist will support the quality management system (QMS) of a pharmaceutical operation, ensuring that documentation, training, and compliance activities are performed efficiently and in line with regulatory expectations.

Key responsibilities

• Support QMS/SOP management, including document control, preparation, review, updates and ensuring controlled documents are current.
• Act as local training coordinator, distributing and coordinating assigned trainings to employees.
• Support deviation management and CAPA execution with documentation, tracking actions to closure and assisting investigations.
• Assist in vendor and distributor quality oversight, following up on quality issues and performing documentation checks.
• Perform quality review of batch and release documentation, checking completeness and quality.
• Handle product quality complaints, providing data review, case checks and timely tracking.
• Participate in internal audits and health‑authority inspection readiness activities, supporting meetings and document preparation.
• Collaborate with cross‑functional teams and external partners to implement risk‑mitigation measures and ensure regulatory compliance.
• Maintain accurate QA records and contribute to quality metrics for continuous improvement.
• Escalate quality risks promptly according to established procedures.
• Act as backup for the affiliate Quality Responsible Person (QRP).

Required profile

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Engineering or a related field.
• 1–2 years of experience in the pharmaceutical industry or a similarly regulated environment.
• Basic understanding of quality management systems, CAPA processes and document control.

Required skills

• Quality Management System (QMS) knowledge.
• SOP and document control expertise.
• CAPA management.
• Training administration.
• Product complaint handling.
• Audit support and inspection readiness.
• Vendor/distributor quality oversight.