Pharma Technical Writer - Quality & Investigations

Sun Pharmaceutical Industries Ltd; New Brunswick, Northern (NJ, KY); Hybrid; USD 74,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

401(k) savings plan

Paid time off

Job summary

Sun Pharma in New Jersey seeks a Technical Writer to support investigations and QA records in manufacturing and packaging operations. You will assist cross-functional investigations for OOS, OOT, CAPAs, and change controls, ensuring timely closure and alignment with QA documentation standards.

Requirements include a Life Sciences or Pharmacy degree, strong communication, project management skills, and familiarity with GDP/GMP.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or equivalent required.
• Demonstrated excellent communication: verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• A team building champion driving innovative cross functional synergies.
• Excellent project management and problem solving skills.
• Excellent computer skills; MS Office (Word, Excel, PowerPoint), TrackWise, EDMS, Outlook.
• Knowledge of GDP, GMP, QA documentation, QA batch records, Quality Systems, Archiving, Retrieval, EDMS workflow, Document Life Cycle and Audit Compliance.
• Intermediate-B1+ English language proficiency (CEFR) for this role.

Responsibilities

• Ensure timely closure of all manufacturing/packaging and QA records.
• Organize and participate in reviews of cross-functional investigations.
• Represents Operations at cross-functional meetings.
• Work with process owners and SMEs to implement agreed upon procedural documentation and to 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 involving manufacturing or packaging control.

Skills

Technical writing

Pharma manufacturing

Cross-functional collaboration

Quality systems

MS Office

EDMS

Outlook

Education

Bachelor's degree in Life Sciences or Pharmacy

Tools

TrackWise

EDMS

Outlook

Job description

Sun Pharma in New Jersey seeks a Technical Writer to support investigations and QA records in manufacturing and packaging operations. You will assist cross-functional investigations for OOS, OOT, CAPAs, and change controls, ensuring timely closure and alignment with QA documentation standards.

Requirements include a Life Sciences or Pharmacy degree, strong communication, project management skills, and familiarity with GDP/GMP.