Theresa Lessingh

Experience

• 

  Aspen South African Operations

  Jan 2011 - Nov 2013

  Review and approval of executed manufacturing batch documentation for quarantine and full release for packing. Ensure GMP compliance on the manufacturing floor, including line clearance and verification of manufacturing steps in accordance with GMP and process requirements. Deviation investigation and root cause analysis.

  • Document Control Pharmacist

    Sept 2012 - Nov 2013

  • Production Pharmacist

    Jan 2011 - Aug 2012
• 

  Aspen Pharma Group

  Dec 2013 - May 2021

  Maintaining the quality systems and reporting thereof for the Marketing Authorization Holder. Quality evaluation of changes from third party suppliers and management of the implementation of changes that have regulatory impact according to project timelines. Assist with market and distribution queries. Ensuring compliance to quality procedures. Assist with the successful roll-out of new quality management systems within the company. Quality and regulatory evaluation of manufacturing site and third-party changes. Compilation of datapacks for regulatory submission. Approval of site master documentation to compliance with product dossier requirements and quality requirements. Assist with the creation of internal audit schedules on a risk-based approach and monitor compliance thereto. Compilation of risk assessments for specific events or non-compliances. Regulatory evaluation of changes proposed by manufacturing sites and ensure compliance with product dossier requirements. Compilation of datapacks for regulatory submission.

  • Quality System Manager

    Jan 2020 - May 2021

  • Quality Systems Compliance Pharmacist

    Oct 2016 - Dec 2019

  • Regulatory Compliance Pharmacist

    Dec 2013 - Sept 2016
• 

  Aspen South African Operations

  May 2021 - now

  Ensure the management oversight of the sites quality management system with continuous improvement initiatives. Oversee the regulatory affairs activities and support decisions according to priority submissions. Manage quality-related activities for the external supply operations with product manufactured by contract manufacturers. Facilitate the review of procedures in line with regulatory requirements. Maintaining the Aspen SA Operations sites quality systems and implement alignment of the policies and procedures to the Aspen Group and regulatory guidelines. Assist the co-ordination of regulatory and customer audits for sterile and oral solid manufacturing sites.

  • Quality Systems and Pharmaceutical Affairs Manager

    Aug 2023 - now

  • Quality System Manager

    May 2021 - Jul 2023