Vanya Varbanova

• Maintenance of QMS system - CAPA, deviation, change control management.
• Control and preparation of batch release documentation
• PQR evaluation
• Document management in eDMS and Quality forward
• SAP Netweaver workflow control

Batch release of non-sterile drug products

• Batch record revision
• Documentation approval
• PQR approval
• Training of the personnel

www.chemaxpharma.com

Microbiological control of the environment, products and personnel in production area; also includes analyses of:

• Non-sterile drug products;
• Primary and secondary packages;
• Internal control;
• Purified water;
• Environmental monitoring in clean room;
• Microorganisms (biochemical identification);
• Culturemedia;
• Media preparation;
• Antimicrobial activity of substances for pharmaceutical use;
• Method validation;
• Www.chemaxpharma.com

Actualisation of documentation from the Quality assurance system established in the company.

• Working according to GMP regulations and related changes, corrective and preventive actions;
• Quality management reports etc.
• Batch record revision
• Training of the personnel
• Internal audits
• Mainly in sectors: Human blood products; Culturemedia; In-vitro diagnostic products
• Www.bulbio.com

• Company Overview: www.sopharma.bg
• Microbiological control of the environment, products and personnel in production area; also includes analyses of:
• Sterile and non-sterile drug products;
• Primary and secondary packages;
• Internal control;
• Purified water;
• Water for injection;
• Environmental monitoring in clean room;
• Microorganisms (biochemical identification);
• Culturemedia;
• Media preparation;
• Activity of antibiotics;
• Tracing on production equipment;
• Antimicrobial activity of substances for pharmaceutical use;
• Www.sopharma.bg