Quality Assurance Specialist

Quality Assurance Specialist needed to perform the following duties:

  • Oversee quality compliance for partner agreements, external and internal audits, and quality, supply chain and warehouse operations procedures.
  • Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.
  • Provide administrative assistance to the Serialization team and CMOs to ensure DSCSA compliance.
  • Review labeling, advertising, and promotional labeling to ensure compliance to policies and guidelines.
  • Maintain knowledge of current/changing regulations/guidelines/standards and co-ordinate with regulatory teams at manufacturing facilities
  • Assist in the review and revision of SOP’s, protocols, and special studies required for compliance with batch record.
  • Assures compliance to SOP’s and cGMP’s.
  • Support and coordinate with the QA team on training requirements, product releases and review of batch records, deviations, and investigations.
  • Review of Material Management forms to assure accuracy of information and components for production.
  • Draft and maintain Quality documents/filings as per requirements.
  • Responsible to monitor the Production floor to ensure all operations are being performed according to written procedures.
  • Responsible for timely completion of regulatory projects and submissions of documentation to regulatory agencies.
  • Review documents/reports for regulatory submissions as per USFDA guidelines and other international cGMP norms.
  • Review additional information/responses as requested by regulatory agencies.
  • Ensure compliance to relevant regulations as standards by evaluating and addressing product/process changes and deviations from regulatory commitments.

Bachelor’s Degree is required in Pharmaceutical Science or Pharmacy or Drug Regulatory affairs or Pharmaceutics

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