Regulatory Affairs Pharmacist Midrand - Midrand
XCaliber Staffing
Our client has a track record of nearly 3 decades the Medical industry They are a leading South African based distributor of high-quality medical consumables and equipment, working with professionals in both private practice and state health facilities. They are looking for their next superstar Regulatory Responsible Pharmacist As their new Regulatory Responsible Pharmacist, here's what you'll do: Operationally be involved with all aspects of the distribution processes and quality issues of the total organization. Responsible for the co-ordination and management of review, updating, compilation and submission of CTD dossiers to SAHPRA. Overall responsibility to ensure that ALL operations are conducted according to the requirements of The Medicines and Related Substances Act (Act 101 of 1965), as amended, and The Pharmacy Act (Act 53 of 1974), as amended, as well as in accordance with the requirements of any other related legislation including Medical Device Regulation (2016) and ISO standards applied i.e., ISO 13485. Act as a Responsible Pharmacist for the company including the warehouse and the applicant. The Responsible Pharmacist shall be responsible to The Pharmacy Council for any act performed by or on behalf of the company. What you will need: A minimum of 5 years experience as a Regulatory Responsible Pharmacist from the Pharmaceutical/ Medical/ FMCG Manufacturing industry essential Matric plus BPharm Registered with SAPC Regulatory Affairs experience a must have Warehousing and Distribution experience In depth knowledge of Regulations, Acts, and Guidelines SAHPRA experience a MUST HAVE
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