QA Training & Compliance Specialist

Cipla; Fall River (MA); Hybrid; USD 66.000 - 86.000; Vollzeit

Zusammenfassung

Cipla is seeking a Quality Assurance Associate - Training & Compliance in Fall River, MA to lead training governance, document management, and quality systems initiatives. You will manage change controls, assess risk, and support regulatory compliance across the site.

The role requires a bachelor’s degree in a related field and at least two years of experience with New Hire & training programs, MasterControl, and CFR guidelines.

Qualifikationen

• Minimum of a bachelor’s degree in chemistry, Pharmaceutical Sciences, Quality Management or related field from an accredited institution.
• Minimum of two years of experience with New Hire & training Program Management, Site Training Governance, MasterControl & Document Management Leadership and Quality Systems & Change Management.
• Working knowledge and direct application of cGMP and regulatory guidelines related to QA, pharmaceutical manufacturing.
• Relevant understanding and knowledge about CFR Part 11 and CFR Part 820 regulations.
• Preferably have prior MDI experience or in Drug Device combination products.

Aufgaben

• Lead Quality Systems & Change Management initiatives and manage change controls related to training systems and document management processes.
• Perform impact assessments and risk evaluations for quality system changes and recommend implementation approaches.
• Lead cross-functional change control activities to ensure compliance and timely closure.
• Identify process gaps through audits, trend analysis, investigations, and management review activities.
• Lead or independently manage projects related to training systems, document management, digital transformation, and quality process improvements.
• Participate in regulatory inspections and address training system-related inquiries from auditors and inspectors.

Kenntnisse

New Hire & training Program Management

Site Training Governance

MasterControl & Document Management

Quality Systems & Change Management

cGMP & CFR familiarity

Ausbildung

Bachelor's degree in chemistry, Pharmaceutical Sciences, Quality Management or related field

Jobbeschreibung

Cipla is seeking a Quality Assurance Associate - Training & Compliance in Fall River, MA to lead training governance, document management, and quality systems initiatives. You will manage change controls, assess risk, and support regulatory compliance across the site.

The role requires a bachelor’s degree in a related field and at least two years of experience with New Hire & training programs, MasterControl, and CFR guidelines.