Senior Executive - Manufacturing, Science, And Technologies

Apotex Inc.; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Accommodation for applicants with dis­

Job summary

Apotex Inc. is a global health company dedicated to making medicines affordable and accessible. We seek a skilled professional to support technology transfer, PLCM, process validation, and CPV activities across the product lifecycle.

You will provide shop-floor technical support, lead documentation and data integrity efforts, and collaborate with cross-functional teams including QA, Regulatory, and Supply Chain to ensure compliant manufacturing readiness and continuous improvement.

Qualifications

• 5–7 years in a GMP pharma environment.
• Hands-on shop-floor experience with oral solids.
• Experience in Tech Transfer, PLCM, Process Validation, CPV.
• Experience with QMS: Deviations, CAPA, Investigations, Change Controls.
• Strong technical writing and communication skills.

Responsibilities

• Support Tech Transfer, PLCM, and product launches.
• Prepare and review protocols, reports, SOPs, and validation documents.
• Provide shop-floor technical support and troubleshoot processes.
• Maintain GMP compliance and support regulatory submissions.
• Coordinate cross-functional activities with QA, QC, Eng, Regulatory, and Supply Chain.

Skills

TrackWise experience

Oral solid dosage manufacturing

GMP knowledge

Regulatory knowledge (USFDA/Health Can

Technical writing

MS Office / data analysis

Problem-solving

Communication skills

Education

M.Pharm (Pharmaceutics or QA)

Validation/Quality Systems/Six Sigma certs desirable

Tools

TrackWise

MS Office

Job description

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com .

Job Responsibilities

Technology Transfer & New 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.

Knowledge & Skills

• Experience with TrackWise or equivalent electronic quality systems preferred.
• Strong knowledge of oral solid dosage manufacturing.
• Understanding of GMP, ICH guidelines, QRM and validation requirements.
• Knowledge of USFDA, Health Canada, and EMA regulatory requirements.
• Strong technical writing, problem-solving, and communication skills.
• Proficiency in MS Office and data analysis tools.
• At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.
• We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.