Validation Officer
East London, Eastern Cape, South Africa
Job Description
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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
- Act as a technical/ subject matter resource
- Facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Provide input into changes or improvements to processes, tools and techniques
- Perform validation exercises in compliance with GMP standards and validation schedules
- Maintain compliant status of equipment and processes
- 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
- 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
- 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 yearsxe2x80x99 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
- Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products
- 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
- Interrogating information
- Maintaining accuracy
- Following procedures
- Technical writing
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Job Detail
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Job IdJD1292712
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationEast London, Eastern Cape, South Africa
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EducationNot mentioned