QA Operations Specialist

Cipla•Fall River, MA

3d•Onsite

About The Position

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. The QA operation specialist (MDI) position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team.

Requirements

Bachelor’s degree in Pharmaceutical science or Equivalent.
Minimum of 3 to 5 years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.
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.

Nice To Haves

Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
Experience in MDI or combination products is preferred.

Responsibilities

Review 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 Standard Operating 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.