Validation Administrator at The Biovac Institute

The Role

The Biovac Institute requires a Validation Administrator (FTC 1 year) to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification. The successful incumbent will report to Validation Manager

Job Purpose

• Responsible for Validation Administrative activities to ensure product quality including but not limited to:
  • Assist in day-to-day validation operation requirements.
  • General administration and duties which include compiling validation reports, sending out results, archiving of results, scanning, filing of results and completed reports into SharePoint.
  • Filing of completed hardcopy records/files in Archive.
  • Assist in managing validation schedules/plans.
  • Assist in downloading of mapping data for report preparation and trending.
  • Assist in Preparing documents and preparation of work packages for Scientists.
  • Follow up on outstanding results to ensure that the validation department meet turnaround times.
  • Following up of on validation documents circulating for review and approval.
  • Ensure timely and effective communication and follow-ups with stakeholders.
  • Administer SharePoint for validation documentation workflow approval process and tracking.
  • Upload, prepare, distribute, and download validation documents on Adobe Sign as required.
• Responsible to ensure that the Validation department and it’s respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
• Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
• Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

Key Duties & Responsibilities

Administrative Activities:

• Assist in day-to-day Validation operation requirements.
• General administration and duties which include compiling validation reports, sending out results, archiving of results, scanning, filing of results and completed reports into SharePoint.
• Conversion of scanned validation documentation into object character recognizable (OCR) form and filing them in SharePoint.
• Assist in managing Validation Schedules/Plans.
• Assist in preparing documents and preparation of work packages for Scientists.
• Managing of the Filing System to ensure efficient retrieval of validation document.
• Following up of on validation documents circulating for review and approval.
• General administration and duties which include compiling Validation reports, sending out results, archiving of results, scanning, and filing of results and ordering of stationary.
• Ensure timely and effective communication and follow-ups with stakeholders.

Quality Management

• Building own cGMP knowledge and compliance
• Participate in achieving the company’s quality objectives.
• Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
• Ensuring audit readiness within own role through closing out audit findings timeously
• Ensure Deviations, Change Controls, CAPAs are handled effectively
• Advocate continuous improvement

Technical Competencies required to perform this aspect of the role:

• Computer Literacy, preferable Office 365 package
• Standard Operating Procedures
• Quality management systems
• cGMP knowledge
• Total Quality Management & Quality Management Systems
• Data development, trending, and reporting

Generic Competencies required to perform this aspect of the role:

• Planning, organising, execution, and monitoring
• Creative problem-solving skills
• Stakeholder management
• Action and results oriented
• Assertive and resilient
• Ability to multi-task
• Influencing skills
• Proactive
• Clear, timely and effective communication skills both verbally and in writing.

Experience & industry accreditation/ knowledge

Required:

• At least 1 years’ experience within the Pharmaceutical/ Vaccines manufacturing / Validation; Administration or similar position
• At least 2 years’ experience in quality management systems within a cGMP facility.
• Experience in quality document review is preferred.

Preferred:

• Understanding of Pharmaceutical and Biopharmaceutical related legislations
• Experience in managing databases
• Experience in aseptic (sterile) or Pharmaceutical Manufacturing
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

Qualifications

Required:

• Matric / Grade 12 or equivalent (recognition for prior learning and practical experience)
• Recognition is given to Prior Learning and practical experience.

Other Requirements

• Own reliable transport