Pharma Technical Writer – GMP/QA Documentation Specialist

Sun Pharmaceutical Industries, Inc.; New Brunswick (NJ); On-site; USD 74,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental & Vision

Life Insurance

Disability Insurance

401(k) plan

Flexible Spending Accounts

Employee Assistance Program

Paid Time Off

Job summary

Sun Pharma is seeking a Technical Writer to support investigations and assist manufacturing and packaging operations on investigations, product quality complaints, and cross-functional reviews. The role includes documenting CAPAs, change controls, and ensuring timely closure of Quality Management System records.

The position requires 2+ years in a pharmaceutical environment, strong communication, and project management skills, with a focus on GDP/GMP and QA documentation.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or equivalent required.
• Demonstrated excellent communication: verbal, written and presentation skills.
• Self-starter with hands-on approach and can-do attitude.
• Team-building champion driving cross functional synergies.
• Excellent project management and problem solving skills.
• Knowledge of GDP, GMP, QA documentation, QA batch records, Quality Systems, Archiving, Retrieval, EDMS workflow, Document Life Cycle and Audit Compliance.
• English language proficiency at Intermediate-B1+ CEFR level.

Responsibilities

• Ensure timely closure of all manufacturing/packaging and Quality Management System records.
• Organize and participate in reviews of cross functional investigations.
• Represents Operations at cross-functional meetings.
• Work with process owners and SMEs to implement procedural documentation and develop cross-functional process models.
• Collect input from stakeholders and consolidate comments for conflict resolution.
• Drive the improvement in established KPI’s/metrics for manufacturing and packaging departments.
• Assist operations in responses to internal, corporate, or regulatory audit observations.

Skills

Communication

Project management

Problem solving

Team collaboration

Education

Bachelor's degree in Life Sciences, Pharmacy, or equivalent

Job description

Sun Pharma is seeking a Technical Writer to support investigations and assist manufacturing and packaging operations on investigations, product quality complaints, and cross-functional reviews. The role includes documenting CAPAs, change controls, and ensuring timely closure of Quality Management System records.

The position requires 2+ years in a pharmaceutical environment, strong communication, and project management skills, with a focus on GDP/GMP and QA documentation.