QA Validation Engineer

Piramal Pharma•Bethlehem, PA

4d•Onsite

About The Position

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders. PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

Requirements

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
Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems
Utilize teamwork and problem solving skills across all departments and internally to Quality Assurance
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
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

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