Anna Stasiewicz

Responsible for assurance human resource objectives by recruiting, training, monitoring, and reviewing job contributions.
• Achieves quality control operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Develops quality control plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures
• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

• Supervising the day-to-day activities in the laboratory
• Establishing lab procedures, creating and managing lab-related documentation and organizes laboratory activities
• Representing a laboratory for scientific conferences and workshops
• Evaluating and hiring job applicants, and organizing training and laboratory orientation
• Supervising lab work to ensuring timely completion of service requests

Development and validation of new analytical methods
• Independent planning and implementation of research processes related to the operation of the laboratory
• Perform maintenance and troubleshooting of lab equipment
• Write and maintain SOPs relating to the group’s activities (Analytical method, equipment use and maintains etc.)
• Provide training and supervise junior staff in routine activities
• Participation in the implementation and maintenance of quality systems ISO / IEC 17025 : 2005 and GLP laboratories
• Remain abreast of new technological developments as they relate to the analytical methodology and propose method improvement

• Design, develop, validate and apply analytical methods for testing od APIs, intermediates, reference standards and raw materials and in support of process development activities
• Assist in the production of quantities of API to support pre-clinical and clinical activities by performing testing to ensure the appropriate quality is delivered
• Participate in method transfer to the other departments
• Write and maintain SOPs relating to the group’s activities (Analytical method, equipment use and maintains etc.)
• Generate the necessary data and reports to support clinical trial application submissions for peptide APIs. Record all work and maintain documentation to the required standard
• Remain abreast of new technological developments as they relate to the analytical methodology and propose method improvement

• Provide analytical support to process optimisation and troubleshooting activities for commercial products and projects.
• Provide analytical support for unplanned events arising in manufacturing and quality, using the range of analytical technologies.
• Provide analytical support to Industrial Development Chemists in process change or process optimisation.
• Develop and validate of new and existing analytical methods for raw materials, intermediates, in-process testing and APIs.
• Purchase of new laboratory equipment.
• Train personnel with analytical methods, equipment use and maintains.
• Review analytical documentation.

• Perform the analysis of: raw materials, in-process intermediate samples, API’s, stability samples and cleaning samples in a timely manner according to approved analytical SOPs and as per relevant specification.
• Complete results in a timely manner with attention to the detail of the SOP and documentation.
• Perform routine instruments calibration and calibration check.
• Create and maintain of up-to-date laboratory Standard Operating Procedures (SOPs) and test procedures
• Performed Installation and Operational Qualification of laboratory equipment.

• Perform chemical analysis of finished product samples adhering to Good Laboratory Practice (GLP) standards and the European Pharmacopeias.
• Complete documentation associated with analytical results in a timely manner.
• Undertake comprehensive stock checks and order replenishments of chemicals and equipment as required.
• Monitor the environment within manufacturing areas including particle count, temperature, humidity and bacterial check.
• Perform external audit in contract companies to verify whether activities comply with current Good Manufacturing Practices (cGMP) requirements, company standards and other applicable regulations.
• Sample and test primary packaging materials to ensure adherence to industry standards and Health and Safety requirements.
• Collect and inspect finish product retain samples with regulatory and site standards.
• Generate certificate of analysis of finished products and trend data .