QMS QA Specialist - 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-QMS Coordinator

Location: Hauppauge, NY (Onsite)

Shift: General Shift 8:30AM-5:00PM

Salary Range: $72K - $93K

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. 

Job Overview: The QA role is responsible for monitoring and performing the QMS (Deviations, CAPA, Change controls, Complaint, OOS/OOT etc.), related activities in accordance to the cGMP requirements.

Responsibilities:

• Assist in the implementation and maintenance of the QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (e.g., FDA) requirements.
• Assist in the collection, analysis, and reporting of quality data (e.g., quality metrics, Deviations, CAPA, Change controls and audit findings).
• Support investigations of deviations, OOS/OOT, and customer complaints, ensuring appropriate follow-up and resolution.
• Prepare and review the investigation related to deviation, OOS/OOT, market complaints and other non-conformances.
• Prepare and review the trend related to various QMS elements like Deviations, CAPA, Change Request and complaints etc.
• Provide training and guidance to employees on QMS-related processes and regulatory requirements.
• Familiar with TrackWise applications for handling Deviation, CAPA, Change control etc.
• Prepare and review risk assessment (FMECA) for various facility, equipment, process and particular event etc.
• Support risk assessments and help mitigate any potential quality risks to product safety and compliance.
• Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP’s.Other duties [additional support] that management may assign from time to time.

Educational Qualification and Expertise:

• A bachelor's degree in scientific discipline (e.g., biology, chemistry, pharmacy) or a related field.
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
• Experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment is preferred.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, Trackwise, SAP, and documentation management systems and other business applications.
• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage, spelling, grammar, and punctuation.
• Must have current Good Manufacturing Practices (cGMP) knowledge and 21 CFR Part 820.
• Must be a self-starter and demonstrate initiative by seeking additional training or direction as needed.
• Must have strong organization and leadership skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

Work Experience: Minimum 3-5 years’ experience in pharmaceuticals (DPI, MDI or Injectables preferred).

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.

Equal Opportunity Employer

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to 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.