SUMMARY:
Our client is looking for a Validation Officer for a 9-month contract to be based in Johannesburg.
EE candidates
POSITION INFO:
Job Specification
Technology Transfer
Spearhead the assigned technology transfer projects on site
Maintain a tracker for the technology transfer
Provide TT project updates to all stakeholders
Interact and follow-up with the respective departments to ensure that the
Technology transfer is well executed and successful
Perform a GAP analysis for technology transfer with the sending site and align with the dossier if applicable
Feasibility evaluation of the proposed technology transfer product
Control and monitoring of technology transfer related documents
Draft and Review of product, raw material monographs, BMR, BPR, COA, Specifications, protocols, and other QMS related documents when required
Identify, justify and co-ordinate Analytical Method Transfer
Quality Management
Adhering to quality management systems as per cGMP requirements to maintain a state of control
Adhering to any changes to regulations and guidelines that will impact the quality system
Maintaining best practice departmental procedures in order to ensure effectiveness, consistency in output, and to meet compliance requirements
Draft, review, and approve quality documentation, qualification protocols, study protocols, periodic reviews, process validation, and cleaning validation protocols.
Reviews change controls for impacts invalidation/qualification
Participates and represents quality assurance in risk assessments
Supporting various departments (Stores/QC/Manufacturing/Packaging and Engineering) to maintain a high level of quality standards
Validation and Qualification
Implement and maintain an effective validation program (including cleaning validation) in line with cGMP
Prepares and executes process validation and cleaning validation protocols
Compiles reports
Integrate Validation activity (Equipment, Utilities, Area, Process, Cleaning and Computer Systems validation) with that of other areas to build on in-house expertise, to improve learning & collaboration to deliver better solutions
Develop scientific knowledge within the Validation group (and the departments with which it interacts) and direct its application to ensure enhanced assurance for the patient and effectiveness in the delivery
Rationalise validation documentation (and protocol requirements) to ease project execution and routine compliance activity while assuring patient needs are satisfied
Apply Risk Assessment throughout project lifecycle focusing assessment to quality, efficacy, and safety
Provide direction and expertise in the management of validation activities,
Ensure review and update of validation procedures (Policies, Masterplans, SOPs) for product, equipment, and facilities
Support changes with regulatory impact through the provision of necessary validation documentation and approve, or delegate appropriately, approval of change controls and non-conformances
Trials
- Management of the trial protocol system
Approval of trial protocols
Maintain database of trial protocols logged
Risk Management
Root Cause Analysis
Minimum Requirements
Grade 12
BSc /B. Pharm Degree / relates science degree/ND Analytical Chemistry
Minimum 7 years experience in QA/QC environment
2 to 3 years of work experience in a Pharmaceutical Manufacturing environment is highly advantageous
1-2 years Validation experience
Kindly note that by submitting your application for this career opportunity you agree that Guardian Recruiting may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business.
Please note that only shortlisted candidates will be contacted.
Should you not have heard back within a two-week period, please assume that your application was unsuccessful. All job postings are in accordance with our Client''s BEE requirements. Please only send certificates when requested to do so.
NB! This job is now closed. You can apply for other jobs by uploading your CV.
