Quality Assurance temp

SUMMARY:
6 Month Fixed term contract

POSITION INFO:

Responsibilities

VENDOR MANAGEMENT AND OUTSOURCE

• Support s in department closure of deviations, change controls, CAPAs and investigations
• Submit appropriate monthly Quality metrics as required by manager
• Participate in risk assessment and ensure mitigations are efficacious as required by manager
• Assist in vendor auditing when required
• Perform internal audits as required, generate reports and follow up for closeouts of findings
• Support department with Regulatory audits and other 3rd party audits
• Assist with risk-based approach for Vendor management program
• Assist with the maintenance of the approved vendor''s list
• Work closely with the QA Coordinator and Senior QA officer in ensuring vendor certification is conducted and vendor database as well as AVL up to date.
• Review and approval of vendor certification
• Update and maintain SOPs and Work instructions related to vendor management
• Participate in projects as/when required

ARTWORK

• Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working.
• Coach and provide QA leadership to stakeholders on quality compliance requirements relating to artwork.
• Responsible for the management of all artwork on site
• Develop and design new artwork for cartons, labels, package inserts and patient information leaflets – product and trial
• Amend artwork for cartons, labels, package inserts and patient information leaflets when updates are required – product and trial
• Ensure that translations of text, where applicable are conducted using certified/verified translators and as per the required regulatory requirements of South Africa and Territories
• Liaise and coordinate all artwork activities with the relevant internal and external stakeholders
• Liaise and coordinate all artwork requirements with relevant printers
• Track artwork and report status on all in-process design and printing

• Develop and ensure that relevant SOPs are in place and up to date and aligned to latest regulatory requirements
• Open change controls for changes to artwork where applicable and ensure completion of actions.
• Open Corrective Actions and Preventative Actions (CAPA)  when applicable and ensure effective implementation in order to meet compliance requirements
• Participate as QA project lead for introduction of new Printed packaging material or Artwork as required by manager

Qualifications

• Degree or diploma in Biotechnology, Pharmacy, Biological Sciences or similar field or equivalent
• Recognition is given to Prior Learning and practical experience.

Required:

• At least 3 years’ experience in Quality assurance in a successful pharmaceutical cGMP environment
• Experience in quality and regulatory compliance within a cGMP facility.           

Preferred:

• Working knowledge of Pharmaceutical Manufacturing related legislation
• Experience in pharmaceutical manufacturing
• Experience in having faced successfully local and/ or international quality audits.
• Quality & regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application
• Advance computer skills
• At least 2 years” experience in developing and design of artwork with in-depth knowledge of pharmaceutical regulatory requirements

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