Validation Officer - Port Elizabeth Verfied

Salary Negotiable Port Elizabeth, Eastern Cape Port Elizabeth, Eastern Cape more than 14 days ago 08-06-2016 1:02:16 PM
06-07-2016 1:02:16 PM
Requirements:
- Grade 12
- Engineering, Pharmaceutical or Scientific Degree or Diploma OR Relevant Established pharmaceutical industry experience OR
Trade Apprenticeship
- Minimum 3 to 5 years' Analytical / Production equipment applications experience
- Strong knowledge in the application of Qualification and Validation principles - VMP, DQ, IQ, OQ, PQ, PV, VR & CV
- CGMP, cGLP, GEP and GAMP experience
- Knowledge of control and instrumentation systems
- Process and automated packing experience essential
- Experience in pipe works and ducts essential
- Experience in repair and fault finding essential
- Knowledge of the OHS Act
- Computer literate
- Experience in electrical systems and the reading of electrical diagrams essential

Responsibilities:
- Compile and execute the relevant Qualification and Validation protocols
- Evaluate the results from executed validation protocols
- Generate validation reports and SOP's
- Assist with the generation of User Requirement Specifications
- Assist with process anomaly investigations and CAPA programs
- Contribute to systems / SOP development arising from validation activities and assist production with personnel training
- Liaise with various departments to ensure co-ordinated effective roll out of validation activities
- Ensure all quality management systems requirements are adhered to, including change control and deviation systems
- Assist with the review of the re-validation plan
- Prepare and execute re-qualification as per SOP
- Assess and recommend re-qualification of equipment and utilities as per protocol