Classified

VACANCY

STAFF WRITER | Tuesday August 20, 2024 16:24

 

About Us:

Medswana (PTY) Ltd is a leading pharmaceutical wholesaler, distributor, and importer committed to providing high-quality pharmaceutical products to meet the needs of our clients and ensure the health and well-being of our communities. We are currently seeking a highly skilled and experienced QA & Regulatory Manager to join our team.

Job Summary:

The QA & Regulatory Manager will oversee all quality assurance and regulatory activities to ensure compliance with industry standards, regulatory requirements, and company policies. This role involves the development, implementation, and maintenance of quality systems, as well as managing regulatory submissions and audits.

Key Responsibilities:

Quality Assurance:

  1. Develop, implement, and maintain quality management systems (QMS) in compliance with GMP/GDP regulations.
  2. Conduct internal audits and manage external audits to ensure compliance with regulatory standards.
  3. Oversee the investigation and resolution of quality issues, deviations, and non-conformances.
  4. Implement corrective and preventive actions (CAPAs) to address quality concerns.
  5. Manage the qualification and validation of equipment, processes, and systems.


Regulatory Affairs:
  1. Ensure all products comply with national and international regulations.
  2. Prepare and submit regulatory documents and applications to relevant health authorities.
  3. Monitor changes in regulatory requirements and update company policies and procedures accordingly.
  4. Liaise with regulatory agencies and represent the company during inspections and audits.
  5. Provide regulatory guidance and support to other departments within the company.


Documentation and Training:
  1. Maintain accurate and comprehensive documentation related to QA and regulatory activities.
  2. Develop and deliver training programs to ensure staff are knowledgeable about quality and regulatory requirements.
  3. Manage the documentation control system and ensure timely updates to all quality and regulatory documents.


Minimum Requirements:
  1. Pharmacy Degree
  2. PhD and MSc in a pharmaceutical discipline (advantageous).
  3. Registration with the BHPC as a Pharmacist
  4. Minimum of 5 years of experience in quality assurance and regulatory affairs within the pharmaceutical industry.
  5. In-depth knowledge of GMP, GDP, GVP and other relevant regulatory guidelines.
  6. In-depth knowledge of ISO 13485:2016
  7. Strong analytical, problem-solving, and decision-making skills.
  8. Excellent communication and interpersonal skills.
  9. Ability to manage multiple projects and priorities in a fast-paced environment.


Benefits:

Market-related salary and performance-based bonuses.

How to Apply:

Interested candidates are invited to submit their resumes and cover letters to info@medswana.co.bw

by 22/8/2024