Pharmacist wanted ASAP – Salary R62 500 Per Month
Vacancy Details
Employer: Kontak Recruitment
Regulatory Pharmacist
Based in Midrand
KEY PERFORMANCE OUTPUTS
The successful candidate will be responsible to ensure high standards of pharmaceutical care in accordance with good practice and other legal requirements.
The candidate will be assisting the Responsible Pharmacist (RP) with both Quality Assurance and Regulatory activities for new and existing pharmaceutical products, medical devices and cosmetics.
The candidate will perform the functions of the Deputy Responsible Pharmacist or Responsible Pharmacist in the absence of the Deputy Responsible Pharmacist and/or Responsible Pharmacist.
The responsibilities include the following but are not exhaustive:
QUALIFICATIONS:
The Pharmacist must have:
· B Pharm Degree Registered with South African Pharmacy Council
· Experience: 3 to 5 years in Quality Assurance and Regulatory Affairs within the pharmaceutical industry.
· Experience in Medical devices industry and understanding requirements of Medical Device regulations is an advantage.
· Experience in Quality Control and/or Quality Assurance would be advantageous.
The Employer is seeking candidates who possess the following skills:
• Ability to manage priorities.
• Ability to work on multiple matters at once.
• Analytical and synthesis skills.
• Ability to work across boundaries and inter-departmentally
• Flexibility and diplomacy in interpersonal relationships.
• Fluency in English (written and spoken).
• Proficiency in the use of common and specialized software.
• Ability to meet deadlines.
• Communication skills.
Key Deliverables:
v Ensure compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974 as well as all applicable legislative requirements for the company’s product portfolio and all regulations and guidelines pertaining to the Import/ Export license for medicinal products and Good Manufacturing Practices, Good Housekeeping Practices, Good Pharmacy Practice, Good Wholesaling/ Distribution Practices and the Marketing Code.
v Ensure compliance with statutory/regulatory requirements of the various authorities (MCC, SA Pharmacy Council, NCRS etc.) in South Africa and related authorities in other African countries where products are sold. Compliance with International quality standards and systems.
v Providing regulatory intelligence and advice to the Business Divisions with regards to regulatory changes affecting the importation and exportation of the products.
v Responding to the requests adequately, satisfactorily and timeously for both internal and external customers.
v Compilation of dossiers/technical file for registration applications of new products in South Africa and related authorities in other African countries.
v Maintenance of existing dossiers/technical files, as per Global and local Health Authority requirements. Submission and follow-up of all product registration amendments.
v Management of Quality Control System. Liaise with Source of Supply on all quality related issues. Compilation of release documentation/release of all product, investigation and reporting on customer complaints as per local and company requirements. Investigation of and reporting on defective/rejected product.
v Corporate Governance: Performing all daily activities in line with the company’s policies and Code of Conduct, Integrity & Compliance
COMPETENCIES
Leadership
Document Management
Problem Solving
Quality Assurance
REPORTING STRUCTURE:
Reporting to: Responsible Pharmacist
Number of direct reports: NONE
Apply before Sunday, June 9, 2019 – 35 Days left
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Source: Jobs365
