Remote QA Specialist - Pharma | QMS & Compliance Pro

Placements24; Pretoria; Hybride; ZAR 420 000 - 600 000; Plein temps

Avantages offerts par ce poste

Home office stipend

Remote work flexibility

Learning and development opportunities

Paid time off and holidays

Retirement savings plan with company"

Résumé du poste

Placements24 is seeking a meticulous Quality Assurance Specialist to join a fully remote team in the pharmaceutical sector. You will develop and maintain the QMS, conduct supplier and internal audits, review documentation, and drive CAPAs to ensure regulatory compliance and product quality.

The role requires a Bachelor’s degree in a related field and 3–5 years of QA/QC experience, with strong knowledge of cGMP, FDA guidelines, and ICH.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 3–5 years of experience in QA/QC in pharma.
• In-depth knowledge of cGMP, FDA guidelines, and ICH principles.
• Experience with auditing techniques, QMS implementation, and deviation investigations.
• Proficiency in document control and change management processes.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills, with the ability to effectively communicate with all levels of the organization.
• Ability to work independently, manage time effectively, and meet deadlines in a remote setting.
• Detail-oriented with a commitment to upholding the highest quality standards.
• Familiarity with validation principles (process, cleaning, equipment) is a plus.

Responsabilités

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with regulatory standards (e.g., GMP, ISO).
• Conduct internal and external (supplier) audits to assess compliance and identify areas for improvement.
• Review and approve quality-related documentation, including batch records, SOPs, and validation protocols.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Participate in regulatory inspections and audits by health authorities, acting as a primary point of contact.
• Monitor and analyze quality metrics, preparing reports for management review.
• Provide training to personnel on quality standards, procedures, and regulatory requirements.
• Collaborate with manufacturing, R&D, and other departments to ensure quality is integrated throughout the product lifecycle.
• Stay updated on current Good Manufacturing Practices (cGMP) and other relevant pharmaceutical regulations.
• Contribute to risk management activities and process improvement initiatives.

Connaissances

GMP

ISO

Auditing

QMS

CAPA

Documentation control

Regulatory requirements

Quality assurance

Formation

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Description du poste

Placements24 is seeking a meticulous Quality Assurance Specialist to join a fully remote team in the pharmaceutical sector. You will develop and maintain the QMS, conduct supplier and internal audits, review documentation, and drive CAPAs to ensure regulatory compliance and product quality.

The role requires a Bachelor’s degree in a related field and 3–5 years of QA/QC experience, with strong knowledge of cGMP, FDA guidelines, and ICH.