South African registered pharmaceutical company is looking for an experienced Quality Control Manager to supervise the QC Laboratory and to take care of many of the aspects relating to quality control and validation throughout the company.
Managing and further developing a small team of people within the Quality Control Laboratory. This will include managing persons working as analysts using HPLC, GC and TLC techniques amongst others, as well as managing and controlling the in-
house microbiological testing laboratory. Assisting in maintaining quality management systems in the wider facility. Updating, implementing and improving Standard Operating Procedures relating to all QC processes.
Liaising with production, warehouse and purchasing staff on all issues relating to raw and intermediate materials as well as finished products.
Developing and assisting with the development of new methods and specifications for the analysis of existing and new products as well as raw materials.
This will include TLC, HPLC, GC UV as well as other technologies, as required. Finding and supervising external method developers with regards to developing suitable methods and methodologies to analyse all products.
Taking a keen interest in improving and establishing existing raw material, intermediate and finished product specifications.
Maintaining and further establishing trend analysis and deviation measuring systems. Establishing a new Stability Testing Section for establishing the shelf-
life of own and contract giver products i.e. specifically providing services to outside companies - for raw materials as well as for finished products.
Continuously establishing and reviewing lean cost effective methods relating to Quality Control. Being responsible for establishing a Master Validation Plan for all equipment in the Quality Control Laboratory and validating laboratory methods.
Being responsible calibration of equipment throughout the company, testing for environmental control, quality testing issues relating to production processes and performing the correct statistical analysis thereon -
as may be required throughout the company. Liaising closely with the Regulatory Department on all issues affecting registration and CTD.
Strongly assisting R&D staff and consultants with regards to finding and analyzing the correct materials for use in products as well as developing new products.
Establishing, compiling, managing and controlling budgets for the Quality Control Department. Compiling ongoing and monthly reports with regards to productivity and quality issues.
Training existing and future staff in all relevant areas in order to attain and maintain suitable GLP standards. M.Sc. degree in associated fields from a well recognised University.
The successful person could come from a chemical analytical or microbiological background, but should possess sufficient skills to be able to understand both fields in order to manage them.
Detailed experience with respect to GLP and have the skills or the willingness to learn the skills relating to the compilation of Common Technical Documents (CTDs).
Experience in productively managing people, projects and tasks. At least 3 years experience in a similar position in a similar industry.
Experience with complementary medicines is essential Should you not receive a response within 10 working days, please consider your application as unsuccessful