Job Responsibilities

- Technology Transfer & Current Product Introduction - Support product technology transfer and commercialization activities.
- Prepare and review MFRs, risk assessments, PPQ, CPV, and validation documents.
- Support site transfer, product launch, and manufacturing readiness activities.
- Monitor optimization, demonstration, validation, and commercial batches.
- Product Lifecycle Management (PLCM) - Execute technical assessments throughout product lifecycle.
- Prepare technical summary reports, investigation reports, and PLCM forms.
- Support process optimization and manufacturing efficiency initiatives.
- Assess product and process changes for quality and compliance impact.
- Perform process, quality, CPV, and APQR data trending.
- Manufacturing Process Support - Provide shop-floor technical support for commercial products.
- Troubleshoot manufacturing and process-related issues.
- Investigate process deviations and atypical results.
- Support root cause analysis and CAPA implementation.
- Drive resolution of technical issues.
- QMS & Compliance - Support deviations, investigations, CAPA, and change controls.
- Participate in risk assessments and effectiveness checks.
- Act as SME for product and process investigations.
- Prepare scientific justifications and technical assessments.
- Maintain compliance with GMP, SOPs, and Data Integrity requirements.
- Support TrackWise activities and documentation.
- Data Trending & Continuous Verification - Perform trending of manufacturing, validation, and quality data.
- Support Continued Process Verification (CPV) activities.
- Identify adverse trends and recommend improvements.
- Support APQR/PQR preparation and review.
- Supplier Driven Changes (SDC) - Evaluate alternate API and excipient suppliers.




- Prepare material assessment reports and risk evaluations.
- Assess quality and manufacturing impact of supplier changes.
- Support implementation of approved supplier-driven changes.
- Documentation & Regulatory Support - Prepare and review protocols, reports, SOPs, and technical documents.
- Maintain GMP-compliant documentation.
- Support internal audits, self-inspections, and regulatory inspections.
- Support regulatory submissions and responses.
- Cross Functional Collaboration - Coordinate with Manufacturing, QA, QC, Engineering, Packaging, Warehouse, Regulatory Affairs, and Supply Chain.
- Support product launches, validation programs, and remediation projects.
- Participate in continuous improvement initiatives.
- Execute additional MS&T; activities assigned by management.

Education

- M.Pharm (Pharmaceutics or Quality Assurance)
- Certification in Validation, Risk Management, Quality Systems, or Six Sigma is desirable.

Experience

- 5 to 7 years of experience in a GMP-regulated pharmaceutical industry.
- Hands-on shop-floor exposure in oral solid dosage manufacturing.
- Experience in Technology Transfer, PLCM, Process Validation, CPV.
- Experience in QMS activities including Deviations, CAPA, Investigations, and Change Controls.
- Experience with TrackWise or equivalent electronic quality systems preferred.

Knowledge & Skills

- oral solid dosage manufacturing
- GMP
- ICH guidelines
- QRM
- validation requirements
- USFDA
- Health Canada
- EMA regulatory requirements
- technical writing

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Executive - Manufacturing, Science, And Technologies (Bengaluru)
🏢 Apotex
📍 Bengaluru