Regulatory Pharmacist (Compliance)

Pharma Dynamics

Western Cape, South Africa

Permanent

Jul 28

We seek a seasoned Regulatory Affairs Pharmacist (Compliance) to assist with the implementation and control of Regulatory Compliance in line with current legislation, operational requirements and business needs Key responsibilitiesComplianceIdentify any potential departmental risk for inclusion into the Risk Management program and contribute to the implementation of all RA related risk management activitiesIdentify and assist with the implementation of all pre- and post-registration SAHPRA commitments in South Africa and in neighbouring countries including, but not limited to: ovalidation reports, ostability data obatch documentationTo check, according to a set procedure, that all printed packaging material is current and in line with the marketed product in South Africa as well as neighbouring countriesAssist with obtaining, storing and communicating the latest GmP certificates and audit reports and identify and report deficienciesFinalize API desktops as and when required To ensure the integrity of data of any current or potential Regulatory databaseEnsure that the completion of CCP tasks and trend the status of open CCPs are doneTo assist with the compiling SOPs to improve the efficiency and output of the department and review and update outdated SOPsEnsure the closure of all Corrective and Preventative Action (CAPA) activitiesEnsure compliance of current dossiers in line with SAHPRA approvals, product history and pending approvals as well as in neighbouring countriesManage the launch procedure for all applicable products ready for launch via weekly meetings with the portfolio person as well as the Quality Department. Ensure the complete signoff of artwork, translations, approval of BMR documentation, GMP compliance, sampling plans, applicable reference standards and columns are in place for product launch.Timeous reviewing of all advertising and promotional material in line with Marketing CodeTraining Manage the implementation, recording and control of an electronic training database Vigilance and technical complaintsAssist with the recording and reporting of all vigilance activities and technical complaints and queries with assistance from the Vigilance Officer Complete the Annual vigilance report for SAHPRA with assistance from the Vigilance OfficerLiaise with the Administrative team to ensure sample delivery and/or collection, timeously and accurately Liaise with the Quality department for the investigation of all technical complaintsDeal with all patients telephonic and email queriesGeneral Provide monthly and or weekly reports as and when required

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Pharma Dynamics

Pharma Dynamics is a leading pharmaceutical company. We are one of South Africa's largest generic medicine providers and the country's leading provide...

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