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e.g manufacturing or QA/QC will be an advantage Submission of new products and responses
and/or validation Knowledge of pharmaceutical science 2 to 3 years Pharmaceutical manufacturing experience Knowledge
Job Purpose Job Purpose To lead and manage the Prescription regulatory team to provide superior Regulatory support to relevant departments within the Group to the External partners and Principals and to control and manage team outputs. To ensure legal compliance with the Medicines and Related Substances Control Act and South African Pharmacy Council ensuring timeous processing of regulatory applications. To build and maintain working relationships with the relevant Regulatory Authorities. To assist the RA manager in managing the outputs of the Compay s regulatory team based in India. Required Learning Bachelor of Pharmacy qualification and or equivalent Science Degree A minimum of 4 - 6 years experience in Pharmaceutical Regulatory environment Computer literate with prior experience with MS Office and Lotus notes Previous management experience Key Job Outputs Co-ordination and submission of new product applications Co-ordination and submission of amendments for currently marketed products Policy transfer of MCC and SAPC regulatory authority regulations Internal Training Assisting with internal product queries from relevant departments Core Competencies Knowledge of the Regulatory requirements for medical products in South Africa Leadership skills Ability to prioritise and work to tight deadlines Systems approach Cross-Functional skills: Ability to network liaise and negotiate with others Ability to set standard and objectives and monitor progress Ability to motivate a team Problem solving and decision making skills
manufacturing practises GMP GLP Chemical & Microbiological. Analysis & retention of raw materials bulk
BPharm Degree. 5Yrs QA in Manufacturing environment. Pharmaceutical Industry experience.
Manufacturing and production HPLC and TLC Tests ISO 17025 and Audits Testing of products. Salary R15000.00
Qualification. Exp: 5 Years exp in Production / Manufacturing environment. Knowledge of: Basic Conditions
Tertiary education. 5 Years exp in Production / Manufacturing environment pref in the Pharmaceutical Line
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