eNewsletter Signup
Miles
Km80.5

Animal Health Validation Manager

Prince Edward Island BioAlliance

Apply
E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: Charlottetown, CANADA - PRINCE EDWARD ISLAND Posted Date: 4/24/2013 Position Type: Full time Job Code: Validation Manager Required Education: Bachelors Degree Areas of Expertise Desired: Validation

Description

Job Purpose
The Validation Specialist is to ensure systems and operations are compliant with regulatory and Novartis requirements through preparation of risk assessments, preparation and execution of validation protocols and
final reports. There will be a significant priority to process data analysis, driving continuous process improvement in manufacturing and driving the validation processes forward by managing, scheduling,
execution, and supervision of staff who are involved in assisting protocol execution and whose primary responsibility is to validate equipment and processes.

Major Accountabilities
• Development and execution of protocols and quality risk assessments (i.e. Process Validation, Cleaning Validation, Equipment Qualification, Product validation, and Sterilization validation).
• Responsible for initial and annual requirements such as gowning qualification of personnel, media fills,
temperature mapping and heat penetration studies.
• Documentation and remediation of deviations resulting from validations/qualifications.
• Develop and utilize established protocols to perform validation and qualification tests and provide detailed and accurate analysis of test results, process capabilities, FMEA/Risk analysis, identifying and investigating validation failures/complaints and trend analysis to access areas of non-conformance
• Prepare and update SOPs
• Trouble-shoot and provide guidance, recommendations for solutions for identified validation and qualification issues based upon sound and knowledgeable analysis.
• Schedule the necessary qualifications/requalification’s with minimal impact on the manufacturing schedule.
• Produce validation reports as required including statistical analysis, results analysis and observations.
• Provide assistance and guidance in training co-workers on validation protocols and operating procedures.
• Remain current on legislative, regulatory and technical changes within the industry
• Manage the maintenance of the validation equipment in a qualified/calibrated state

Other:
• Attend necessary training as required in order to stay current with industry
• Complete other duties as necessary.

Job Dimensions
Number of associates: 1 to 3
Financial responsibility:
(Budget, Cost, Sales, etc.)
N/A
Impact on the organization: Ensures compliance w ith internal and external qualification requirements for cGMP manufacturing facilities

Requirements

Background
Education :
B.S. Engineering or Science Degree Diploma
Experience:
3-5 yrs Proven record of Equipment/Process Validation
High proficiency in Word Processing
Working Knowledge of cGMPs
Experience working with multi-disciplinary teams
Advanced communication skills
Advanced problem solving skills
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