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Job Details

Site Validation Lead

Company: Novartis
Location: Ireland Cork City
Reference: 234200BR
Closing Date: 25 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Position Purpose Develops, implements and manages Site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies’ requirements and related SOPs. Major Accountabilities 1. Validation Master Plan Establish, write, maintain Validation Master Plan for process, cleaning and packaging validation. ...

Requirements:

Position Purpose
Develops, implements and manages Site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies’ requirements and related SOPs.

Major Accountabilities
1. Validation Master Plan Establish, write, maintain Validation Master Plan for process, cleaning and packaging validation. Support Site MS&T Head in ensuring that responsible departments execute and maintain the VMP activities including, annual revalidation process and cleaning procedures. Maintain overview of state of validation at Site and establish the project prioritization across site. Partner with Quality based on feedback (e.g. via division, regulatory inspections, changes in regulations) to establish and maintain common approach and translate that for the site Partner with Engineering and IT to define the process validation/ equipment/systems qualification interface. Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritisation of activities against the business needs. Reviews risk assessments for validation. Set local procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments. Maintain all 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.
2. Compliance/Audit Support/HSE: Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit. Annual Product Review/Product Quality Review (APR/PQR): Review the PQR data and provide the correct level of discussion on it.
3. Financial: Identification of future budgetary requirements for area Manage costs within budget and identify & implement productivity improvement opportunities.
4. Validation activities: Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes. Responsible to translate the critical process parameters and the process control strategy into a focused validation plan for process validation.


Minimum requirements

Education
Minimum: BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
Preferred: PhD in the above or equivalent

Experience
• 8 years experience in manufacturing/ manufacturing science and technology/technical development/quality.
• Thorough understanding of manufacturing processes and related process equipment.
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• 5 years experience in executing process validation, having led and managed validation projects.
• Expert in reviewing and writing technical reports.
• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).

Apply for this job: Site Validation Lead

Contact Information:

Address:  Novartis Pharmaceuticals UK Limited
Frimley Business Park
Camberley
Surrey
GU16 7SR
England
Tel:  +44 (0)1276 692255
Fax:  +44 (0)1276 692508
Website:  Visit Our Web Site

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