Do you have the following on your work experience as a Validation Technician, i.e. Cleaning, processing, utilities, equipment, computerized systems? This is your job. Our client in Pharmaceutical is looking for a person with 3 years working experience as a Validation Technician. Knowledge of GMP requirements, validation principles and procedure and industry standards. Wide knowledge of manufacturing systems and operations. Ideally the Line manager is specifically looking for someone with Cleaning validation experience, but is willing to take someone with any of the above processes.

Job purpose
To effectively and independently lead all elements of the Validation Lifecycle for all systems comprising equipment (including control and analytical systems), utilities, facilities, IT systems or cleaning processes as assigned at the Cape Town Factory. Provides functional guidance to Quality Assurance, Production, Engineering and Technical personnel. Conducts self-inspections.

EDUCATION
Education Required Bachelors
Minimum Requirements Matric
BSc or BTech: Engineering, Mechanical or Electrical disciplines
Pharmaceuticals, Pharmacy or related scientific field.

VALIDATION OF CLEANING PROCEDURES.
Validates Cleaning Procedures in accordance with the Site Validation SOPs to ensure compliance to the requirements of the company's QMS Polices, CAPs and local Regulatory requirements.

KPI's
Leads Validation Working Party by scheduling regular minuted meetings to co-ordinate validation activities.
Ensures that cleaning processes are in alignment with the Cleaning Validation Lifecycle approach (i.e. Process Design and Development; Process Performance Qualification and Continued Process Verification).
Facilitates and participates in Technical Risk Assessments (TRA) as per site agreed schedule:
Provides input into equipment qualification working parties in regard to cleaning validation lifecycle requirements.
Co-ordinates cleaning procedure risk assessments.
Prepares the Validation Master Plans, Validation Plans/Protocols.
Develops, executes and records the sampling and test plans.
Carries out or, oversees the performance of, the required monitoring / test plans.
Investigates processing/procedural problems and/or failures and applies effective remedial action (in consultation with Validation, Technical, Production and QA Management).
Coordinates the various validation activities with production and QA personnel.
Arranges for the analysis of samples.
Collates, summarizes and reviews the data.
Ensures preparation (or revision) of applicable system SOPs, standard work and Master Documents.
Prepares the Validation Report(s).
Trains personnel (or assists with the training) with respect to validation requirements and outcomes.
Assures that ongoing monitoring (Continued Process Verification) is in place.
Performs cleaning periodic reviews of validated systems. Ensures maintenance of the validated status or initiates appropriate corrective action.
Revalidates cleaning processes as per the revalidation program or, as required.
Evaluates change control requests for the impact of change on validation status (including updates to product and equipment cleaning matrices as required), assists in developing appropriate change management action plans and supports approved change plans with respect to validation activities.