Pharma Dynamics Current Job Opportunity – Apply Now!

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

 

 

 

 

Job Title: Regulatory Pharmacist (Compliance)
Location: Tokai, Western Cape, South Africa
Reference #: RAP2021
Contract Type: Permanent
Salary: Market Related

Job Summary:
Key responsibilities:
Compliance:
•Identify any potential departmental risk for inclusion into the Risk Management program and contribute to the implementation of all RA related risk management activities
•Identify 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 documentation

•To 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 countries
•Assist with obtaining, storing and communicating the latest GmP certificates and audit reports and identify and report deficiencies
•Finalize API desktops as and when required
•To ensure the integrity of data of any current or potential Regulatory database
•Ensure that the completion of CCP tasks and trend the status of open CCPs are done
•To assist with the compiling SOPs to improve the efficiency and output of the department and review and update outdated SOPs
•Ensure the closure of all Corrective and Preventative Action (CAPA) activities
•Ensure compliance of current dossiers in line with SAHPRA approvals, product history and pending approvals as well as in neighbouring countries
•Manage 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 Code

Training:
• Manage the implementation, recording and control of an electronic training database

Vigilance and technical complaints:
•Assist 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 Officer
•Liaise 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 complaints
•Deal with all patients telephonic and email queries

General:
•Provide monthly and or weekly reports as and when required

Requirements:
PRE-REQUISITES:
•B. Pharm registered with the SA Pharmacy Council
•In dept knowledge of Pharmacology (theoretical and practical)
•4 years Regulatory hands-on experience in a compliance environment

The company reserves the right to adjust or modify the scope and / or level of the job based on applicant supply, operational requirements and/or prevailing market conditions

To Apply:

Click Here!

Application Deadline: 11/08/2021