Validation Officer

7 days ago

Pinetown, South Africa NBISA Recruitment Full time

**Job Advert Summary**:
To ensure compliance with the NBI Validation Master Plan and cGMP requirements in all qualification and validation activities executed at NBI. This includes the compilation of validation protocols, execution of validation activities and compiling technical reports. In addition, to witness related activities of third-party contractors and conduct training where required.

**Minimum Requirements**:

- Matric
- Bachelor’s degree or National Diploma in Chemical Engineering, Process Engineering, Biotechnology, Microbiology, Chemistry, or relevant science or engineering qualification.
- A minimum of 2 years’ experience in pharmaceutical manufacturing or similar environment.
- Prior experience in the qualification/validation of process equipment, manufacturing processes, cleaning procedures, utilities and analytical methods would be advantageous.

**Duties and Responsibilities**:
**Conduct Validation activities**
- Liaise with internal customers, equipment, and process owners regarding requirements for qualifications and validation tasks to which they are assigned.
- Engage with users/suppliers and take an active role for all validation activities taking place at NBI.
- Witness qualification/validation/calibrations conducted by third-party service providers.
- Ensures that all validation activities are executed in a timely manner, following the approved protocols.
- Immediately communicate discrepancies or deviations to protocols or expected outcomes to the internal stakeholders, and ensure that they are investigated and resolved using the internal QMS process.
- Ensure that record keeping and good documentation practices are maintained during the validation process.

**Compile Validation protocols**
- Compile new validation protocols and update existing protocols based on the requirements of the user, taking cGMP and latest guidelines into account for the validation methodology.

**Compile Validation Reports**
- Collect data, documentation and information required for the qualification or validation activity.
- Collate and analyse the validation data obtained to identify possible anomalies from the expected result.
- Compile technical reports and summaries for each of the qualification or validation activities that are conducted.

**Calibration programme**
- Ensure that the instrument calibration schedule is adhered to.
- Ensure that all assigned files and indexes for calibrations are kept up to date.

**Training**
- Compile procedures where necessary and provide training of staff on relevant SOP’s developed during validation.

***Ad hoc**
- Provide support to all the NBI departments regarding validation requirements and issues that may arise.
- Assist with QA related events and activities as and when required.
- Represent the validation team where required.

**Core Competencies**
- Managing relationships
- Personal leadership
- Business Impact
- Leading and Influencing Others
- Engaged and collaborative team player
- Attention to detail
- Quality orientation
- Planning and organising
- Good communication and interpersonal skills
- Analysis and problem solving
- Customer focus
- Technical reporting

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