Quality Assurance Specialist

Qualifications
  Bachelors degree in Pharmacy, Chemistry, Biology, or related life sciences field.
  4+ years of QA experience in a pharmaceutical or biotech environment.
  Strong knowledge of GMP, ICH Q10, FDA, and EMA regulations.
  Experience with quality systems, CAPA management, and validation documentation.

Skills
  Exceptional attention to detail and analytical thinking.
  Strong written and verbal communication skills.
  Proficiency in QA software and documentation tools.
  Ability to work independently and in cross-functional teams.

The QA Specialist will ensure that all products, processes, and documentation comply with regulatory standards such as FDA, EMA, and GMP. This role is vital to maintaining product safety, efficacy, and quality throughout the manufacturing lifecycle.

Responsibilities:

  Monitor and enforce GMP compliance across manufacturing and laboratory operations.
  Review batch records, SOPs, and validation protocols to ensure accuracy and regulatory alignment.
  Conduct internal audits and inspections to identify non-conformances and recommend corrective actions.
  Investigate deviations, CAPAs, and complaints to ensure timely resolution and documentation.
  Support regulatory submissions and inspections by preparing documentation and participating in audits.
  Train staff on quality procedures and compliance standards.
  Maintain and update QA documentation systems including change controls and risk assessments.