What are the responsibilities and job description for the QA Associate (DPI) position at Cipla?
About Cipla
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.
Driven by the purpose ‘Caring for Life’, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
In the last 85 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.
InvaGen Pharmaceuticals, Inc.
InvaGen Pharmaceuticals is a Cipla subsidiary 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. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States.
Job Title
QA Associate II (DPI)
Organization Name
InvaGen Pharmaceuticals
Location
7 Oser Ave, Hauppauge, NY 11788
Employment Type
(Hourly/ Full Time)
Full Time – Salaried/Exempt
Salary Range
(Base/ Hourly)
$65,000 - $80,000
Benefits
In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits
Work Hours/ Shift/ Remote
General Shift: 8:30 AM – 5:00 PM
Responsibilities/ Accountabilities
Job purpose
Performs and oversees cGMP compliance-based services (qualification, validation, APQR, 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.
Duties and responsibilities
The general duties and responsibilities of the "Validation QA" 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 process. 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: protocols and reports, SOPs, impact assessment, specifications URS/FRS/DDS, FATs/SATs etc.
- Perform work to meet company’ requirements and quality standards.
- Maintain departmental compliance pertaining to departmental SOPs.
- Generate, review, 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.
Education Qualifications
- A minimum of a Bachelor’s degree in a relevant field of study from an accredited institution.
- Knowledge of pharmaceuticals, manufacturing, utility, lab systems, and equipment, preferably in solid or semisolid dosage forms.
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical design/commission/validate processes and how they relate to regulatory requirements and cGMP regulations with U.S. FDA.
Experience
- Minimum 1-3 years of pharmaceutical experience.
Physical Requirements
- Sitting at and/or working at a computer or other “screen” 75% or greater of an 8-hour period.
Other Information
- No remote work available.
Equal Opportunity Employer
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.
About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.