Validations Officer

Recruiter:

Talent Evolution

Job Ref:

PTA000980/EO

Date posted:

Thursday, March 10, 2022

Location:

Johannesburg, South Africa

Salary:

R25 000 pm Monthly

SUMMARY:
The Validations Officer will be responsible for conducting a range of validation and compliance activities to support the manufacturing and other departments.

The Incumbent will report to the QA Manager.

JOB DESCRIPTION:

Duties:

Preparation and review of Validation Master Plan and Validation Master Schedule.
Maintaining validation and calibration schedules while liaising with contractors.
Compilation of validation (cleaning validation and process validation) and qualification of equipment and utilities (IQ, OQ and PQ) protocols) protocols and execution of the same.
To prepare CSV documentation to meet 21 CFR Part 11, ISPE, etc; Plans, Protocols and Reports
Initiate and maintain the HTS programme.
To ensure assigned validation exercises are conducted in a timely manner and in compliance with cGMP and project milestones.
To participate in Change Control assessments and project meetings to ensure the compliant status of affected equipment is not compromised.
To participate in corporate, regulatory, and internal audits as necessary.
Focus on process, cleaning and product validation studies and always maintain GMP compliance.
Managing of site validation documentation and completion of validation risk assessments.
Preparation and Review of Departmental SOPs.
Work with QA, Production, Maintenance, and other departments to resolve audit findings.
Review and update of departmental SOPs.

Requirements:

Diploma in in Pharmacy, Chemistry, Biology, Microbiology, or related scientific field
2 - 3 years in Validations
Proven industry experience in validation ideally within a GMP manufacturing environment.
A working knowledge and practical experience with equipment qualification (RA, URS, DQ, IQ, OQ, PQ and PR), cleaning validation, computerized system validation and utilities qualification.
Knowledge of temperature and/or humidity mapping, data processing and reporting.
Advanced working knowledge of Microsoft Office products (Excel, Outlook, PowerPoint, and Word),
Strong troubleshooting , mathematical, analytical, and problem-solving skills.
Demonstrated knowledge of industry best practices (e.g. GAMP and ISPE) across a range of computerized systems
Excellent report writing and data interpretation.
Analytical method verification and validation shall be an added advantage.

Should you not receive a response within 10 working days, please consider your application as unsuccessful

NB! This job is now closed. You can apply for other jobs by uploading your CV.

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