Validation Technician (12-month FTC) - Talent Pool
About this opportunity
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
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