QA Validation - DPI

NOTICE : The posting for local applicants only - is not for those applying for a global assignment and / or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Job Title : QA Validation

FLSA Classification : Professional, Exempt

Work Location : Unit 1, Hauppauge, NY

Work Hours : General : 8 : 30AM - 5 : 00PM (may vary based on business needs)

Reports To : QA Validation Manager

Salary Range : $68,000 - $74,600

Purpose :

The incumbent to this role performs and oversees cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) on equipment and facilities and utilities associated with pharmaceutical manufacturing and drug product development.

Job Overview

Responsible for the coordination of supportive equipment and process validation activities such as testing, calibration, scale-up, engineering and validation studies, and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations.

The job duties for this position include but are not limited to the following :

• Maintain compliance of the validation program to ensure all equipment, facility and utilities are qualified for pharmaceutical processes.
• Oversee equipment calibration and preventative maintenance program by setting and confirming scheduling of all outside contractors and maintaining the equipment database, reviewing, and approving service support certificates / documents.
• Prepare documents following established standards and templates, including but not limited to the following : commissioning Forms, protocols and reports, SOPs, impact assessment, specifications URS / FRS / DDS, FATs / SATs etc.
• Perform work to meet company' requirements and quality standards.
• Represent facility and engineer to communicate with internal and external stakeholders. Provide consistent, complete, and timely feedback, project status and issues, and reports to project managers and senior management.
• Maintain departmental compliance pertaining to departmental SOPs, periodic review and reporting of the environmental monitoring system.
• Generate, review, approve and maintain Validation Master Plan and summary reports and other Process validation lifecycle documents.
• Evaluate process validation projects to establish protocols and test plans.
• Collect and analyze all data, write final reports and obtain approvals.
• Review technical documentation such as batch records, SOPs, calibration records, preventive maintenance work orders, protocols, reports.
• Perform gap assessments and remediation as required on legacy validation packages.
• Interface with the FDA and customers during site audits to respond to validation-related questions.
• Assist in deviation investigation and resolution of problems and oversee change control requirements for all projects and work orders.

Education and Experience

Technical Knowledge and Computer Systems Skills

Professional and Behavioral Competencies

Work Schedule and Other Position Information

GLOBAL COMPANY

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.