Senior QA Specialist

 

Recruiter:

ABC Worldwide

Job Ref:

CPT001338/CB

Date posted:

Monday, November 8, 2021

Location:

Capetown, South Africa


SUMMARY:
Our client is one of the leading sterile vaccine manufacturers rooted in Africa.  Their core purpose it to “protect life”.  They are looking to hire a dynamic, passionate, confident, proactive and meticulous Senior QA Specialist to join their goal-oriented team.

POSITION INFO:

QUALIFICATIONS NEEDED
 

  • Degree or Diploma in Microbiology / Biotechnology, Pharmacy or equivalent
 
NECESSARY 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 principles
 
KEY 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 company’s 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
 
Should you meet all the requirements and wish to apply, please send your latest CV and motivation to --------Please upload your CV here-------->

 

NB! This job is now closed. You can apply for other jobs by uploading your CV.



 

 

 

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