eNewsletter Signup
Miles
Km80.5

Senior Quality Oversight Validation Specialist

Novartis Pharmaceuticals Corporation

Apply
E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: San Carlos, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 107040BR Required Education: Bachelors Degree Areas of Expertise Desired: Engineering
Quality Assurance
Validation

Description

Summary:

This senior position is responsible for providing quality oversight to ensure GMP equipment, process, systems, and facility/utilities are qualified and maintained in a validated state. Performs the QA review and approval of equipment and analytical instrument qualification, cleaning and process validation, and computer system qualifications. Provide guidance and instruction to users of validation policies, programs and procedures. Author and maintain the Site Validation Master Plan for equipment, instruments and computer system. Maintain the Validation Master List of systems and their qualifications at the San Carlos site. Interfaces with groups such as Engineering, Process Development, and Manufacturing to ensure that the design, implementation and qualification of equipment, systems and processes is conducted according to established quality standards. As a Quality representative to change controls, will provide guidance and instruction to users of change control policies, programs and procedures. Provides QA oversight for deviations related to equipment, utilities and the facility. Provide guidance and instruction to users of deviation policies, programs and procedures.

Essential Duties and Responsibilities:

• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Works on complex issues where analysis of situation or data requires an in-depth evaluation of variable factors. Exercises judgments in selection of methods, techniques, and evaluation criteria for obtaining results. Adept at risk management tools and applying principles
• Determines methods and procedures on new assignments
• Leads projects and determines resources with senior managements input
• Sets the QA Validation department objectives and determines their achievements
• Provide compliance input to the validation activities, change requests, and deviation resolution activities
• Participate on project teams to implement new systems & equipment to the facility
• Participate on project teams to implement and maintain global systems, which the San Carlos site may use
• Provide support to individuals and teams requiring guidance on implementation of changes, documentation of deviations and their resolution, and general validation topics.
• Provide training to company and contracted personnel on validation, change control, and deviation policies and procedures.
• Reviews and approves protocols and reports
• Reviews and approves system specifications, project plans, risk assessments
• Reviews and approved revalidation assessments
• Reviews and approves change request for equipment, analytical instruments, and process changes
• Reviews and approves deviations related to equipment, utilities, and facilities.
• Author and maintain policy and procedures to ensure site compliance through validation and change control activities
• Provides Line Unit review and approval of SOPs
• Independently manages QA Validation department workload, tasks, & projects
• May supervise Novartis staff and/or contractors supporting validation, change control or deviation management.

Requirements

• Bachelor’s degree in an engineering discipline. Equivalent experience may be accepted.
• A minimum of 8 years relevant work experience is required.
• A minimum of 5 years direct validation experience is required.
• Must be able to demonstrate knowledge of validation principles including user requirements, functional specifications, commissioning, IQ, OQ, PQ and process validation.
• A thorough knowledge of cGMP and regulatory requirements for validation is required.
• A working knowledge of or hands-on experience with utilities and general production systems used in manufacturing, testing and holding of non-sterile pharmaceutical manufacturing is required.
• Must be able to demonstrate an understanding of design and development concepts such as, DOE, FMEA and technology transfer.
• Strong word processing and spreadsheet skills are required.
• Good communication skills both oral and written are required.
• Must be able to demonstrate excellent customer service skills.
• Strong attention to detail regarding documentation is a must.
• Must be well organized, and willing to work as part of a team.
• Strong working knowledge of statistics and analysis tools.
Apply
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS