Validation Technician (12-month FTC) - Talent Pool

Job purpose

• Accountable for the following:

• Stay updated on the latest validation methodologies, standards and technologies through independent research, industry publications and professional networking.

• Participate in mentorship sessions with other validation personnel and actively contribute insights gained through learning experiences.

• Ensuring continuous learning is integrated into daily activities.

• Apply new skills and knowledge daily.

• Develop and maintain a structured approach to managing activities, including timelines, milestones and deliverables.

• Maintain clear and concise records of executed activities, methodologies and outcomes ensuring transparency and accessibility.

• Engage with team members to seek guidance from mentors and incorporate feedback to align outcomes with departmental needs.

• Ensure that all activities adhere to industry standards, regulatory requirements and internal policies and procedures.

• Identify challenges and propose solutions to overcome obstacles within the project space.

• Prepare reports and presentations summarizing insights, lessons learned and recommendations for improvements.

• Responsible for the following:

• Executing validation activities and procedures to ensure compliance with industry standards and regulations.

• Gather and analyse data, documenting findings and reporting discrepancies

• Identify areas for optimization validation processes and suggest improvements.

• Maintain accurate records and ensure that all documentation aligns with regulatory requirements.

• Participate in testing, troubleshooting and support corrective action implementation.

• Stay updated on validation methodologies and industry best practices.

• Ensure that the Validation department and its respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements.

• Ensure that Validation requirements are achieved at the required quality and regulatory levels (Biovac, SAHPRA, WHO, pharmacopoeia) and within the agreed timeframes.

• Prepares protocols and reports for all executed activities based on company standards/guidelines, procedures, and Industry current practices.

• Coordinates the validation activities with related departments.

• Tracking and expediting the review and sign-off of validation documentation.

• Assist during internal and 3rd party audits regarding validation requirements by interacting with auditors during inspection or audits.

• 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.

Minimum qualification(s)

Required:

• Completed qualification within any field of Natural/Health Sciences/ Engineering.
• Recognition is given to Prior Learning and practical experience.

Experience & industry knowledge Required:

• Experienced in writing of technical documents.
• Basic experience in testing and troubleshooting practices.
• At least 6 months in a qualification / validation role within the pharmaceutical industry.

Preferred:

• Basic knowledge of Pharmaceutical Manufacturing.
• Familiarity with data integrity principles and documentation best practices

Core Technical Delivery

• Liaising with service providers.
• Participate in Process Development activities.
• Execution and documentation of validation processes: Process Development, Process Validation, Cleaning Validation, CSV, Mapping, Cold Chain, Facility Decontamination, Periodic Reviews and Periodic Revalidations as per defined timelines and according to cGMP
• Participates in troubleshooting a wide range of problems which requires creative thinking.
• Exercises significant technical discretion in design, execution, and interpretation, and pursues new validation/qualifications studies as a result of experimental outcomes.
• Communicate status and any delays/ issues/ changes experienced during validation.
• Communicate with departments regarding validation planning and time needed on validation activities.
• Provide guidance to staff from other departments regarding the required content of procedures.
• Manage internal customer relations and communication.
• Ensure relevant OOS and OOT investigation non-conformances/ deviations, change controls and CAPA’s are initiated and completed to the correct standard.
• Identify quality risks in the section and initiate risk management where required, e.g. to support investigation or choices.
• Management of Validation equipment – usage as per procedures, housekeeping, and ensuring equipment remain calibrated and maintained by communicating to Engineering department
• Prepare validation and qualification protocols and compilation of reports
• Maintenance of a structured documentation archive
• Presenting of validation and qualification work during company audits and inspections

Technical Competencies required to perform this aspect of the role:

• Pharmacopoeia methods, standards, guidelines and relevant agency recommendations on QC testing.
• Documentation Management
• Inventory Management
• Environmental, Health & Safety Management
• Statistical Trending & Data Analysis
• Metric Development & Report Writing
• Review & Auditing Skills

Supporting Quality Management

• Building own cGMP Knowledge and Compliance.
• Participate in achieving Quality Culture, Quality Objectives and Quality Risk Management.
• Ensuring audit readiness within own role through closing out audit findings timeously.
• Ensure Deviations, Change Controls, CAPAs are handled effectively.
• Advocate continual improvement.
• Ensure a state of accuracy across all documentation within own span of control in support of achieving optimal quality across Biovac.

Technical Competencies required to perform this aspect of the role:

• cGMP vaccine manufacturing- quality and regulatory compliance & best practice knowledge e.g. PIC/s, SAHPRA requirements,
• Total Quality Management & Quality Management Systems
• Data trending &Technical report writing
• Presentation skills during company audits