30 Jun '20
Validation Officer (Pharmaceutical)

Pharmaceutical, Gauteng JHB - Western Suburbs

R R400k pa - R R450k pa

A contract pharmaceutical manufacturing company, seeks to employ Validation Officer to work in the Validation Department. As the Validation Officer you will be responsible for conducting a range of validation and compliance activities to support the manufacturing†and other departments

Duties:

  • You will be responsible for maintaining validation and calibration schedules while liaising with contractors.
  • To prepare CSV documentation to meet  21 CFR Part 11, ISPE, etc; Plans, Protocols and Reports 
  • 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 maintain GMP compliance at all times. 
  • 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 finding.

Requirements:

  • 1 – 2 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) protocol and report compilation.
  • Knowledge of temperature/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 computerised systems
  • Excellent report writing and data interpretation.
  • Cleaning validation activities will be an added advantage.

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

 

Ad Visible Until: 30 July 2020
Ref: PTA000702/EO

Vacancy Type: Permanent