Job Title
QA Validation Engineer
Job Description
Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will be responsible for change management activities and ownership of site validation program compliance, including ensuring compliance, improving practices, and qualifying/validating new processes, equipment, and systems with company strategic goals as a guide. The role may also serve as a liaison between the Operations group, including manufacturing, packaging, engineering, maintenance, and other functions, and the QA/QC department for day-to-day activities, capital projects, process improvements, and related initiatives.
Essential Duties and Responsibilities:
• Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility systems
• Schedules, plans, manages and executes studies for cleaning validations
• Schedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocols
• Reviews and approves validation project documentation
• Coordinates and interfaces with the process unit heads, quality and engineering groups to ensure successful project executions
• Leads and coordinates cross-functional teams for project validation
• Priorities, manages and executes multiple projects utilizing the project management methodologies
• Oversees external validation resources
• Supports the development of best and proven validation practices in the validation department based on current industry guidelines and practices
• Authors relevant standard operating procedures for ensuring compliance with the company's policies
• Supports regulatory submissions and also regulatory agency inspections whenever requested
• Champions continuous improvements in the validation department

Key Competencies (knowledge, skills and abilities every person must possess to be successful)
• cGMP and Regulatory Compliance - Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretation, lead and/or conduct investigations, employ logic, and implement decisions from within the Quality Assurance organization
• Professional Communication - Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
• Computer Literacy - Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems
• Collaboration - Utilize teamwork and problem solving skills across all departments and internally to Quality Assurance
• Project Management - The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manner

Education / Experience
• Bachelor's degree or higher in relevant scientific/technical field
• Total Combined Years: 4 or more years within industry or Regulatory/Compliance, including project management experience preferred
• Experience in project management
• Must be well organized with a keen attention to detail
• Knowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to time

Physical Demands:

Physical Effort (Occurrence frequency for each activity)

Standing/Walking/Sitting: Frequently

Balancing/Kneeling: Occasionally

Crouching/Stooping/Crawling: n/a

Reaching/Working Overhead: Occasionally

Keyboard Use/Repetitive Hand Motion: Frequently

Climbing/bending: Occasionally

Pushing/Pulling (up to 25 pounds): Occasionally

Lifting/Carrying (up to 25 pounds): Occasionally

Working Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Moderately undesirable working conditions (i.e., occasional exposure to significant levels of temperature, air pollution, noise pollution, chemical gases and substances. Possibility of physical trauma conditions of a minor nature such as cuts, bruises and minor burns).

Reporting to this position: N/A

General Oversight and Direction:

Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions or previous training. Employee handles some situations independently.

The above statements reflect the general duties and responsibilities considered necessary to perform the essential functions of the job. This document should not be considered a fully detailed description of all the work requirements of the position. Piramal Critical Care may change the specific job duties with or without prior notice based on the needs of the organization.