Lead Validation Eng

Description

ESSENTIAL FUNCTIONS / SKILLS :

• Development and execution of documents including but not limited to : FAT, SAT, IQ, OQ, PQ, and PV
• Review and approval of validation documents including but not limited to : GxP Assessment, Risk Assessment, Part 11 / Annex 11 Assessment, Data Integrity Assessments, IQ, OQ, PQ, Summary Reports, URS, FRS, DS and Traceability Matrix.
• Familiar with Development, QA and Production environment terminology and testing strategies.
• Complete equipment periodic review
• Responsible for change management validation functional review
• Temperature mapping of controlled environments
• Development and review of laboratory equipment qualification protocols
• Development and review of cleaning validation protocols. Basic understanding of LD50 / HBEL derived maximum carryover limits
• Collection of cleaning samples – swab / rinse, etc. as required
• Performs validation document review and approval
• Responsible for validation procedures, template creation and software validation process improvements
• Reviews / approves validation deviation investigation
• Develops validation plans for multiple site implementation
• Responsible for document management including scanning and archival of validation documents
• Familiar with data integrity guidance from MHRA and FDA
• Management of data integrity gap assessments and remediation
• Performs equipment / system / process level risk assessments per ICH Q9 guidelines

DEPARTMENT SPECIFIC / NON-ESSENTIAL FUNCTIONS :

MINIMUM REQUIREMENTS :

Bachelor’s degree in a science / engineering related field is preferable with related technical background

Minimum of 10 years’ experience in review / approving validation in a pharmaceutical manufacturing environment. Proven personnel and project management history. Complete knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11 and Data Integrity requirements. Knowledge of ICH Q7 , Q9, and Q11 preferred.

COMPETENCIES :

Focus, Drive for Results, Managing Through Systems, Written Communication, Customer Focus, Listening, Organizing, Comfort around Higher Management, Multi-tasking, Prioritization, Risk Based Decision Making, Managing Diversity, Motivating Others

RELATIONSHIPS WITH OTHERS :

PHYSICAL / VISUAL ACTIVITIES OR DEMANDS :

ORGANIZATIONAL RELATIONSHIP / SCOPE :

Reports to the Manager Quality Validation. Must be self-directed to manage validation activities (local and remote sites). Operates independently under limited supervision.

WORKING CONDITIONS :