Validation Officer

3 weeks ago

East London, South Africa Aspen Pharma Group Full time

**Overview**

Perform validation exercises of production and lab equipment, utilities, packaging and processes to ensure specific standard of compliance is met

**Responsibilities**

**Planning and Operational Support**
- Facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Provide input into changes or improvements to processes, tools and techniques

**Validation**
- Perform validation exercises in compliance with GMP standards and validation schedules
- Maintain compliant status of equipment and processes

**Qualification**
- Perform the relevant operational qualification protocols as per SOP to ensure new equipment / utilities/ packaging function as per intended use
- Perform the relevant performance qualification protocols as per SOP to ensure new equipment / utilities/ packaging function as intended over time and within limits
- Investigate and report OOE results, and perform re tests
- Participate in change control assessments to ensure compliant status of affected equipment is not compromised
- Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered to
- Ensure documents and procedures to operate and maintain equipment are in place

**Requalification**
- Assess and recommend re qualification of equipment and utilities as appropriate as per Protocol
- Prepare and perform re qualification of equipment and utilities as per SOP

**Reporting and Record-Keeping**
- Compile, maintain and update validation documentation as per SOP and QMS
- Generate validation reports on a weekly/ monthly basis

**Skills Required**:
**Background/experience**
- National Certification (N4 N6) or Trade Tested Artisan with 2 4 years’ related experience
- Degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
- Aseptic pharmaceutical manufacturing process and automated packing experience

**Specific job skills**
- Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives

**Competencies**
- Interrogating information
- Maintaining accuracy
- Following procedures
- Technical writing

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