Job Description

About the Role:

• Ensure compliance with the Validation Master Plan and cGMP requirements of all validation associated activities executed. This includes the drafting of required validation protocols, execution of validation activities and compilation of validation reports.
• Oversee Validation Officers and Validation Interns day-to-day tasks ensuring all validation requirements are timeously met and conduct training where required.

Minimum Job Requirements:

• Bachelors Degree or National Diploma in Chemical Engineering, Biotechnology, Chemistry, or related Science or Engineering field.
• At least 5 years experience in a Pharmaceutical Manufacturing environment with working knowledge of pharmaceutical facilities, equipment, laboratories, utilities and systems is required.
• Min 3 years specifically in validation of equipment, manufacturing processes and analytical methods, and utilities.
• Min 2 years experience in a supervisory role, supervising staff within a team.

Key Performance Areas:
Report to the Validation Manager:

• Validation Planning and Execution:

• Execute qualification and re-qualification projects affecting all aspects of pharmaceutical validation, namely equipment, facility, utility qualification/s, computer system and cleaning validation, etc.
• Monitor project progress against the Validation Master Plan and report on progress.
• Ensure compliance of the validation processes and procedures followed with all aspects of cGMP, GLP & GAMP, and Good Validation Practice.
• Plan, co-ordinate and oversee routine and non-routine activities of the Validation Officers/Interns day-to-day tasks.
• Assist the Validation Manager with planning of the Validation Master Plan execution, timeline and resource allocation.
• Conduct meetings with the Validation team on their project focus.
• Assist with validation master plan updating.
• Provide detailed and accurate feedback to the Validation Manager and other departments, to highlight areas where continuous improvement in the quality departmental activities are required.
• Ensure that all validation activities are executed in a timely manner following the approved protocols and any discrepancies are noted, investigated and closed off.
• Manage all re-validation activities.
• Provide feedback and liaise with external service providers to ensure compliance with company requirements of validation activities.
• Represent the Validation Manager when delegated.
• Validation Documentation:

• Manage the drafting of validation protocols and their status on the document management system.
• Compile validation protocols based on the requirements of the user, taking into account cGMP and other relevant guidelines.
• Initiate and drive compilation of validation protocols of major projects.
• Execute all aspects of quality documentation associated with validation.
• Prepare and implement a robust system for filing and retrieving of reports, certificates and related validation documentation.
• Keep the Validation Master Library up to date.
• Validation Reporting:

• Manage timely completion of Validation reports generated by the Validation team.
• Review analytical data and conduct statistical analysis for validation reports.
• Compile process validation studies/protocols.
• Collate and review the validation data obtained and compile validation reports for each validation activity conducted.
• Quality Systems:

• Initiate and complete impact and risk assessments related to validation projects to ensure validation activities are conducted according to a risk-based approach.
• Implement corrective and preventive measures within the team following any non-conformances or deviation identified during validation studies.
• Calibration and Re-qualification Programme:

• Ensure that all validation instrumentation is calibrated on time as per preventative maintenance schedule.
• Perform internal calibration and verification of QA validation temperature probes used for mapping and calibration studies. Conduct calibrations of specialised data loggers.
• Co-ordinate, monitor and witness calibrations and testing of validation elements.
• Administration of critical instrument calibration and all calibration certificates.
• Training:

• Compile SOPs where necessary and provide training of staff on relevant SOPs developed during validation.
• Drive the compilation of Validation SOPs.
• Validation Sample Management:

• Sample different locations, or equipment for microbiological and chemical testing.
• Sample in-process products for validation.
• Log samples in the LIMS system.
• Manage (including handling and storage) samples to ensure sample integrity and that they are processed and delivered to the relevant laboratory correctly.
• Capture results from the LIMS system and collate them for reports.
• Liaise with laboratories for results and sampling plans.

Core Competencies:

• Effective interpersonal skills and emotional intelligence.
• Quality orientation and awareness.
• Excellent planning and organising skills.
• Strong analytical and problem solving skills.
• Ability to work independently with minimal supervision.
• Excellent technical writing skills is required.
• Ability to handle typical team conflicts.
• Personal leadership.
• Business impact.
• Lead and influence others.

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