QA Validation DHF - DPI

Job Title: QA Validation & DHF

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

• A bachelor's degree in scientific discipline (e.g., biology, chemistry, pharmacy) or a related field.
• Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
• Minimum 1-2 years’ experience in pharmaceuticals (DPI, MDI, oral solid or Injectables preferred).

Technical Knowledge and Computer Systems Skills

• Effective interpersonal relationship skills and the ability to work in a team environment.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Capable of supporting and participating in compliance and regulatory audits at the local and federal levels.

• Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.
• Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.
• Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
• Must be able to work under minimal supervision and able to work independently and in a team environment.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same.
• Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.
• Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.

• Knowledge of good manufacturing practices and good documentation practices preferred.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organizational skills with the ability to focus on details.

Work Schedule and Other Position Information

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing to work some weekends based on business needs as required by management.
• No remote work available.
• This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.
• The role may be assigned on a work Weekend or Holiday work may be requested or required based on business needs.

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.