Senior Quality Assurance Specialist

Placements24; Klerksdorp; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Medical cover

Dental and vision coverage

Vacation and sick leave

Professional development opportunities

Retirement savings plan

Collaborative work environment

Job summary

Placements24 is recruiting a Senior Quality Assurance Specialist for its Klerksdorp facility in the North West region. The role focuses on developing and maintaining the QMS, conducting internal audits, and managing deviations and CAPAs to ensure pharmaceutical quality and regulatory compliance.

The ideal candidate has 5+ years of QA experience in pharma/medical devices, with strong cGMP/ICH knowledge, data analysis skills, and effective documentation abilities.

Qualifications

• Bachelor’s degree in a life science field (Pharmacy, Chemistry, Biotechnology) is required.
• Minimum 5 years of QA experience in pharmaceutical or medical device industries.
• Strong knowledge of cGMP, ICH guidelines, and regulatory requirements.
• Experience with internal audits, deviations, and CAPA systems.
• Proficiency in data analysis and technical report writing.

Responsibilities

• Oversee and maintain the Quality Management System (QMS) to ensure cGMP and regulatory compliance.
• Conduct internal audits of processes, documentation and facilities.
• Investigate deviations and non-conformances; implement effective CAPA actions.
• Review and approve critical quality documents (batch records, SOPs, validations).
• Participate in external audits by regulators and customers.

Skills

Regulatory knowledge

Auditing

CAPA

QMS implementation

Data analysis

Technical report writing

Communication

Collaboration

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biotechnology or related life science

Tools

Electronic QMS software

Job description

About the Role

Our client, a reputable entity within the pharmaceutical industry, is seeking a meticulous and experienced Senior Quality Assurance Specialist to join their dedicated team in Klerksdorp, North West . This role is essential for ensuring that all operations, processes, and products adhere to stringent quality standards and regulatory requirements. The successful candidate will be responsible for developing, implementing, and maintaining the quality management system, conducting internal audits, and managing deviations and CAPAs. This position offers a significant opportunity to contribute to the integrity and compliance of pharmaceutical products manufactured by our client. The ideal candidate will possess a strong understanding of quality principles and a commitment to excellence in the Klerksdorp facility.

Key Responsibilities

• Oversee and manage the company's Quality Management System (QMS), ensuring compliance with cGMP, ISO, and other relevant regulations.
• Conduct internal audits of manufacturing processes, documentation, and facilities to identify areas for improvement and ensure compliance.
• Manage and investigate deviations, non-conformances, and customer complaints, implementing effective corrective and preventive actions (CAPA).
• Review and approve critical quality documents, including batch records, validation protocols, and standard operating procedures (SOPs).
• Participate in external audits by regulatory agencies and customers, acting as a key point of contact.
• Develop and deliver quality training programs for employees to ensure a strong quality culture throughout the organization.
• Monitor key quality metrics and provide regular reports to senior management on the status of the QMS and product quality.
• Support continuous improvement initiatives aimed at enhancing product quality, process efficiency, and regulatory compliance.
• Stay updated on evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.
• Ensure all activities performed in the Klerksdorp facility meet the highest quality standards.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
• A minimum of 5 years of experience in Quality Assurance within the pharmaceutical or medical device industry.
• In-depth knowledge of cGMP, ICH guidelines, and other relevant regulatory requirements.
• Proven experience in conducting internal audits, managing deviations, and implementing CAPA systems.
• Strong understanding of pharmaceutical manufacturing processes and documentation.
• Excellent attention to detail and organizational skills.
• Proficient in data analysis and technical report writing.
• Effective communication, presentation, and interpersonal skills.
• Ability to work independently and collaboratively within a team environment.
• Experience with electronic QMS software is a plus.
• Commitment to maintaining high standards of quality and compliance in North West .

Benefits

• Annual salary range: R.
• Comprehensive medical, dental, and vision coverage.
• Paid time off, including vacation, sick leave, and public holidays.
• Opportunities for professional development and certifications.
• Retirement savings plan.
• A collaborative and supportive work environment in Klerksdorp .
• Exposure to a wide range of pharmaceutical products and processes.
• Career advancement opportunities within a well-established company.