QA Validation Engineer

Piramal Pharma Limited

Bethlehem (Northampton County)

On-site

USD 95,000 - 135,000

Full time

4 days ago

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Job summary

Piramal Pharma Limited, a global leader in critical care solutions, seeks a QA Validation Engineer for our Bethlehem, PA site. You will drive cGMP compliance, own the site validation program, and coordinate with manufacturing, engineering, and QA/QC to qualify processes, equipment, and systems.

The role requires a Bachelor’s degree and 4+ years in pharma validation or regulatory/compliance, with strong project management and communication skills.

Qualifications

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

Skills

cGMP compliance

Regulatory compliance

Professional communication

Computer literacy

Collaboration

Project management

Education

Bachelor’s degree or higher in relevant scientific/technical field

Tools

Microsoft Outlook

Excel

Word

Job description

Be the First to Apply Division Piramal Critical Care 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. For more details, please visit https://www.piramalcriticalcare.com/global/

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.

Equal Employment Opportunity

Piramal Critical Care is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all associates and applicants without regard to age, sex, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disabled veteran or Vietnam Era Veteran Status. Americans with Disabilities Act Applicants as well as employees who are, or become, disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

Employee Job Responsibilities

You are expected to follow all policies, procedures and guidelines, conducting yourself in ways that protect the interests and safety of all employees and the company. 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.