GMP Production Technical Writer | QA & Compliance

SUN PHARMA; New Brunswick (NJ); On-site; USD 74,000 - 85,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) savings plan

Flexible spending accounts

Employee assistance program

Vacation time

Sick time

Job summary

Sun Pharma in New Jersey seeks a Technical Writer to support investigations and quality records within manufacturing and packaging operations. You will assist cross-functional investigations for OOS, OOT, CAPAs and change controls, and help ensure timely closure of records in the Quality Management System.

You will collaborate with process owners and SMEs to develop procedural documentation, participate in cross-functional reviews, and support internal and regulatory audits while maintaining

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or equivalent.
• Excellent verbal, written, and presentation skills.
• A 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.
• Intermediate-B1+ English proficiency (CEFR).

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 improvements in KPIs/metrics for manufacturing and packaging departments.
• Assist operations in responses to internal, corporate, or regulatory audit observations.

Skills

Communication

Self-starter

Team building

Project management

Problem solving

English proficiency

Education

Bachelor's degree in Life Sciences, Pharmacy or equivalent

Tools

MS Office

TrackWise

EDMS

Outlook

Job description

Sun Pharma in New Jersey seeks a Technical Writer to support investigations and quality records within manufacturing and packaging operations. You will assist cross-functional investigations for OOS, OOT, CAPAs and change controls, and help ensure timely closure of records in the Quality Management System.

You will collaborate with process owners and SMEs to develop procedural documentation, participate in cross-functional reviews, and support internal and regulatory audits while maintaining