QMS Specialist

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

QMS Specialist

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Central Islip, NY location

Employment Type

Full Time

Salary Range

$70K - $90K

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

Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.

Responsibilities/ Accountabilities

• Conduct thorough investigations of Out of Specifications (OOS), Out of Trend (OOT), Deviations, including data collection, root cause analysis, complaints and identification of contributing factors.
• Utilize various root cause analysis (RCA) tools (e.g., 5-whys, fishbone diagrams, Etc.) to determine the underlying causes of deviations.
• Maintain detailed and accurate records of investigations, including findings, recommendations, and CAPA plans.
• Work with various departments (e.g., QA, AQA, manufacturing, quality control, engineering, etc.) to gather information and implement CAPAs.
• Implement, and track CAPAs to address the identified root causes and prevent recurrence.
• Effectively communicate investigation findings and recommendations to various stakeholders, including management.
• Maintain detailed records of investigations, CAPAs, and any other related documents.
• Prepare summary data as required and submit to management.
• Other duties [additional support] that management may assign from time to time.

Education Qualifications

• Minimum bachelor degree in Science, Pharmacy, or related field

Experience

• 3-5 years of relevant experience in pharmaceutical manufacturing, particularly in Quality/QMS roles.

Skills/ Competencies

• Knowledge of Good Manufacturing Practices and Good Documentation Practices.
• Ability to have technical writing skills related to QMS documents.
• Ability to work effectively in a cross-functional and cross cultured team environment.
• Self-motivated, with the ability to work independently.
• Strong knowledge of cGMP norms, root cause analysis, CAPA management, and proficiency in QMS software.
• Excellent organizational and analytical skills with the ability to focus on details.
• Experience with QMS Systems (TrackWise) • Basic computer skills (Microsoft Word, Power Point and Excel).
• Shall be abreast of regulatory guidelines such as CDER, CHRA, ICH, USP Monograph, etc.

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.