Rose Shianah

Established and managed a pharmaceutical quality system that included management review, document control, training, customer feedback and complaints, internal audits, vendor audits, process improvement, and corrective/preventative action (CAPA) activities in one year. Created, implemented, and maintained all policies and procedures in compliance with GxPs.

• Supervised, trained, and evaluated a staff of three QA Officers
• Trained and qualified Internal Auditors. I have extensive experience in internal, corporate and supplier audits against regulatory requirement, technical agreements and Safety Data Exchange Agreements. I am a certified CQI Pharmaceutical Quality Practitioner and a certified IRCA PQS Lead Auditor.

  IRCA Lead Auditor: PQS, ISO 13485 and 9001.

Established and managed a pharmaceutical quality system that included management review, document control, training, customer feedback and complaints, internal audits, vendor audits, process improvement, and corrective/preventative action (CAPA) activities in one year. Created, implemented, and maintained all policies and procedures in compliance with GxPs.

• Supervised, trained, and evaluated a staff of three QA Officers
• Trained and qualified Internal Auditors. I have extensive experience in internal, corporate and supplier audits against regulatory requirement, technical agreements and Safety Data Exchange Agreements. I am a certified CQI Pharmaceutical Quality Practitioner and a certified IRCA PQS Lead Auditor.

  IRCA Lead Auditor: PQS, ISO 13485 and 9001.

  Associate

  Auditor IIASA.

BTech Quality Management

National Diploma in Analytical Chemistry