Closing Date: 25 Oct 16
Type: Full Time
Salary (£): On Application
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement. Think what's possible. Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings. Submit your CV/resume now to join our talent pool for the position described below. ...
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement. Think what's possible. Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings. Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information. ENTER JOB DESCRIPTION HERE Novartis is an Equal Opportunity Employer.
Key responsibilities include:
Establish, generate and, maintain Site Validation Master Plan and associated technical SOPs for all validation, revalidation and periodic review activities on-site.
Support Site MS&T Head in ensuring that responsible departments execute and maintain the VMP activities including, annual revalidation process to the required technical standards.
Assess and approve Change Control proposals to ensure validation strategy is consistent with Alcon validation requirements.
Establish and manage the individual project validation plans by aligning, coordinating and supervising the prioritisation of activities against the business needs. Review risk assessments for validation.
Maintain governance of all validation activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities.
Advise validation practitioners on all aspects of validation planning, testing strategy and execution.
Identification of future budgetary requirements for the area
Manage costs within budget and identify & implement productivity improvement opportunities.
Support equipment and process qualification for new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering.
Provide assessment of and input to Quality Modules (QM)/Quality Directives (QD)/global Standard Operating Procedures (SOPs) and Technical Guidance Documents (TGDs) to ensure documents are in line with global/local requirements and industry standards.
Participate in improvement and remediation of products.
Liaise with external customers and other Alcon sites as part of daily role.
Engage with broader Alcon Validation Lead community to benchmark best practice in validation approaches and collaborate in implementing global MS&T vision. Minimum requirements Degree in Engineering, Technology or similar technical discipline
Extensive Equipment and Process & Software Validation experience.
At least 8 years’ experience in manufacturing/manufacturing science and technology/technical development/Quality with direct experience in a validation role in either medical device or pharmaceutical industry.
5 years’ experience in executing process validation, having led and managed validation projects
Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
Demonstrable knowledge of FDA, medical device, cGMP and validation requirements.
Excellent communication and skills – written, oral and pc.
Novartis Pharmaceuticals UK Limited
Frimley Business Park
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