QA Validation Engineer

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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.

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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.