QA Associate - Validation DPI

Cipla•Hauppauge, NY

7d•Onsite

About The Position

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. 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.

Requirements

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).
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.
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.
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.
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.

Nice To Haves

Knowledge of good manufacturing practices and good documentation practices preferred.

Responsibilities

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.