Anel Clark

Freddy Hirsch

QA

Chief Laboratory officer and Assistant Quality manager

Tasks at Freddy Hirsch included: • Resolved and investigated the non- conformances from production • Managed the day-to-day activities of the analytical lab and other quality issues. • Managed staff members including their responsibilities, performance reviews, shift roster, transport and leave schedule. This also included competency testing and training staff on HACCP and food safety. • Overseen the Supplier and raw material approvals, managed customer complaints • Tested and loaded the specifications of the for new products and shelf-life extension • I attended the management and food safety meetings and lead the morning meetings • Managed the laboratory chemicals and consumables stock levels as well as the ordering and installation of new equipment. This also included the maintenance and calibration of the laboratory equipment • Executed special projects assigned by my QC Manager • I did internal and external audits and represented the lab during external audits. • I did staff competency testing and trained them on new SOP's and other new procedures. • I also conducted Supplier audits and assisted the procurement department on raw material approvals • Handled customer complaints: Investigation and feedback.

Synexa Life Sciences

Project Planner

Section head and laboratory manager

Synexa Life Sciences started out as a biotechnology company and I started in the bacterial culturing/ fermentation section. I did fermentation (shake flasks and bioreactor based cultures, protein purification, protein precipitations and finally HPLC/GC MS assays, Later on the lab was used for pesticide analysis. Two years later I was offered the Section head post for Flow and cell based assays as well as the Specialized Diagnostic laboratory at Synexa Life Sciences. Bacterial culturing/fermentation: • Prepared samples for chromatographic analysis • Run and analysed samples in GC,GC-MS and HPLC Specialized diagnostic lab: • I successfully setup the lab for SANAS accreditation (ISO 17025) • Method validation • Sample reception and processing of the samples, performing routine diagnostic testing (ELISA's, flow cytometry and rapid testing for instant M2PK and Calprotectin tests) • Performed different flow cytometry assays to diagnose and treat infertile patients. • Did different ELISA assays to measure hormone levels. • Inventory control: Reagents and equipment. • I was appointed as the Assistant LIMS administrator and therefor was responsible for result entry and reporting, • I had to maintain the lab for the SANAS accreditation. • Reviewed results for microbiology samples tested. Clinical Trial laboratory: Assisted clients with biomarker research using techniques to best analyze and interpret what the client needed. • Validated new methods and assisted the clients with new method development. • Liaised with the client and project management compiling budgets and attended weekly meetings. • Compiled the standard operating procedures for these methods and had to oversee and make sure the sample acquisition and analyses were processed according to SOP's • Compiled the data and make sure its QC passed and have audit trails as set by GCLP. • Evaluated and validated new kits and compiled validation reports • Manufactured QC samples for various techniques. One of these controls is Lymphosure, which is currently used as a control in Flow cytometry • Trained current staff, students and interns • Managed the maintenance and calibration of all equipment as per schedule My duties as a section head and laboratory manager also included: • I managed ± 12-15 employees • I did the performance reviews, competency testing and training of staff • Handled the customer complaints • Compiled a division of the management review report • Checked, verified and maintained the labs EQA systems • Problem solving including technical problems • Chaired the weekly meetings • Represented laboratory and done internal and external audits

Masters

University of Stellenbosch

MSc Medical microbiology

Honours

Cape Peninsula University of Technology

BTECH BIOMEDICAL TECHNOLOGY

Diploma

Cape Town University of technology

Medical Technology (Clinical pathology)

Prof Patrick Bouic

Director

Synexa Life Sciences

0826038120

Magdeleen Swart

Manager

Freddy Hirsch

0829390611