Associate, IPQA (Amneal)

Roles and Responsibilities

Key Responsibilities

• Provide administrative and operational support for global Phase 1–4 clinical trials for NCE products.

• Maintain Trial Master File (TMF) and ensure timely filing and quality control of essential documents (ICH-GCP Section 8).

• Track study milestones, study trackers, site initiation, patient recruitment progress, and study close-out activities.

• Support protocol amendments, Investigator’s Brochure (IB) updates, and Informed Consent Form (ICF) revisions.

• Assist in preparation of study-related documents including monitoring plans, site manuals, and training materials.

• Support preparation and submission of regulatory and ethics committee packages (IND/CTA submissions, amendments, annual reports).

• Maintain regulatory correspondence and submission trackers across regions.

• Support safety reporting documentation coordination (SUSARs, DSURs, PSURs).

• Coordinate communication with global clinical sites, CROs, laboratories, and vendors.

• Assist with site selection documentation, feasibility questionnaires, and site contracts documentation tracking.

• Assist in reconciliation of clinical trial documents, data listings, and monitoring reports.

• Ensure compliance with ICH-GCP, regulatory guidelines (FDA, EMA, CDSCO), and internal SOPs.

• Participate in audit and inspection readiness activities (TMF audits, vendor audits, regulatory inspections).

• Collaborate with internal and external stakeholders to implement AI/ML in the department.

• Schedule global team meetings, prepare meeting minutes, and track action items.

• Support preparation of clinical program reports and management presentations.

• Maintain clinical project documentation repositories and version control.

• Literature review, compilation, and presentation

Essential Functions:

• Perform IPQA (In-Process Quality Assurance) checks during manufacturing and packing operations

• Execute and document Line Clearance and Readiness for manufacturing, packing, and dispensing

• Conduct In-Process Checks & Sampling (In-process, Stability & ANSI)

• Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs)

• Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and completeness

• Ensure Good Documentation Practices (GDP – Good Documentation Practices) compliance.

Qualifications

Education:

• B. Sc- Required

• B. Pharm - Preferred

Experience:

• 1 year or more in 1 - 4 Years