QA Operations 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 : QA Operations Specialist



F LSA Classification :Full-Time,Exempt/SalaryProfessional



Work Location :Fall River, MA



Work Hours: General Shift: 8:30AM - 5:00PM (May very based on business needs)



Reports To :



Salary Range:

Job Purpose:


The purpose of the QA operation specialist (MDI) position is to monitor and ensure validation and qualification of facility, utilities, equipment's, processes and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs) and to provide guidance to QA associates.

Duties and Responsibilities:


The QA operation specialist (MDI) position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The essential and typically expected job duties for this position include but are not limited to the following:

• R eview and approve qualification and validation protocols and reports including URS, FDS, FAT, SAT, DQ, IQ, OQ, and PQ, along with all supporting documentation.
• Review and approve User Requirement Specifications (URS) for equipment, systems, and utilities.
• Prepare, review, and approve Process Validation protocols and reports in accordance with lifecycle validation principles.
• Prepare, review, and approve Cleaning Validation protocols and reports for product contact equipment and manufacturing areas.
• Ensure all qualification and validation activities are planned and executed in alignment with applicable regulatory requirements (FDA, EU Annex 15, ICH Q8/Q9/Q10) and internal StandardOperating Procedures (SOPs).
• Collaborate with cross-functional teams (Engineering, Manufacturing, QC, Regulatory Affairs, IT, etc.) to support new projects, equipment implementation, and changes requiring validation.
• Provide Quality Assurance oversight during equipment commissioning, facility upgrades, and utility system qualification activities.
• Ensure risk assessments (e.g., FMECA) are performed and documented for validation and qualification activities.
• Maintain and manage the Validation Master Plan (VMP) and ensure periodic review and timely execution of requalification/revalidation activities.
• Participate in the investigation of deviations, out-of-specification results, and non-conformances related to validation, contribute to development and closure of effective CAPAs.
• Ensure validation and qualification documentation supports data integrity and is compliant with 21 CFR Part 11 for computerized systems.
• Maintain all validation lifecycle documents in accordance with company policies and cGMP expectations, ensuring traceability and audit readiness.
• Support internal and external audits, including FDA and other regulatory authority inspections, by providing relevant validation records, responses, and justifications.

Education and Experience:

• Bachelor's degree in Pharmaceutical science or Equivalent.
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
• Minimum of 3 to 5 years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.
• Experience in MDI or combination products is preferred.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, TW 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.
• Must be a self-starter and demonstrate initiative with 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.

Working conditions


This role works in a cGMP manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical manufacturing facility is required.


The role may be assigned on a work-shift basis, where required (Day, Evening, Night). Weekend or Holiday work may be requested or required.

Physical requirements

• Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to 10 kg, may be required.
• Able to always wear appropriate personal protective equipment, when required.
• Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Professional and Behavioral Competencies:

• Must be willing to work in pharmaceutical manufacturing and packaging quality assurance.
• Must be willing and able to work any assigned shift ranging from first or second shift. Work schedule may be Monday to Friday.
• Must be willing to work some weekends based on business needs as required by management.
• No remote work available.

GLOBAL COMPANY

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.Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary: InvaGen Pharmaceuticals, Inc. is 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. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement:

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.