Cipla USA · 17 hours ago
QA Validation - DPI
Hauppauge, NY
Full-time
Onsite
Entry Level
$68K/yr - $75K/yr
1+ years expCipla USA is a leading global pharmaceutical company dedicated to high-quality medicines. They are seeking a QA Validation professional responsible for overseeing compliance-based services on equipment and facilities associated with pharmaceutical manufacturing and drug product development.
Pharmaceuticals
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
Qualification
Required
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
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
Preferred
Knowledge of good manufacturing practices and good documentation practices
Company
Cipla USA
Cipla USA, the wholly owned subsidiary of Cipla (established in 1935), has been enabling patient access to affordable and high-quality medicines in the US for over 30 years.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Arunesh Verma
President & CEO, Cipla North America
Marc Falkin
Executive Vice President / Chief Commercial Officer
Company data provided by crunchbase