Job Description

QUALIFICATIONS NEEDED? Degree or Diploma in Microbiology / Biotechnology, Pharmacy or equivalentNECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGE? At least 5 years experience in Quality Assurance within the pharmaceutical/ biotech/API
manufacturing industry Sound technical ability in the field of operational Quality Assurance
? Experience in Quality Management Systems within a sterile manufacturing cGMP facility
? Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application.
Project management in Quality Assurance
? Sound application of Risk Management and technical report writing
? Understanding of Validation & Qualification principles, Quality by design principlesKEY DUTIES & RESPONSIBILITIES OF THE ROLE

• Review and approve minor and major deviations and escalate critical deviations to the manager
• Review and approve CAPA in order to meet compliance requirements
• Review and approve minor and major change controls for quality and regulatory compliance impact

and determine requirements for implementation

• Coordinate and participate in risk assessments and ensure mitigations are efficacious when

applicable

• Review and approve SOPs and Work instructions for responsible areas
• Review, approval and sign-off all operational documents and records, e.g. periodic re-qualification,

periodic-revalidation including both Protocols and Reports to ensure compliance with site
approaches, cGMP and regulatory agency requirements

• Act as a QA lead on critical deviations, investigations, Risk assessments and Root cause Analysis as

required

• Ensure that the activities in the Quality Assurance Department are achieved at the required quality

levels (SA GMP, PIC/s and WHO). Analyse and write annual trend reports where applicable.

• Support Quality Assurance with customer audits, Regulatory audits and other 3rd party audits;

perform internal and supplier audits and compile audit reports; assist HOD and Manager on follow
up and close out of audit findings timeously.

• Ensure compliance to all applicable regulations and internal procedures by proactively interpreting

regulatory and quality requirements and determining way of working

• Participate in achieving the companys quality objectives
• Participate in building a sustainable quality culture on site and proactively mitigate risks that may

negatively impact quality or escalate these appropriately

• Ensuring audit readiness within own role through closing out audit findings timeously. Participate in

projects as / when required

• Ensure project deliverables delivered as per agreed timelines and quality. Key decision maker on

quality aspects of allocated projects

• Ensure quality by design, risk-based approach and risk assessments conducted and mitigated where

appropriate in accordance with project timelines

• Ensure Change management, Risk management are incorporated into all allocated projects

ABC Worldwide