Quality Senior Specialist (QMS)

Teva Active Pharmaceutical Ingredient; Palanpur; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Teva Active Pharmaceutical Ingredient in Palanpur, Gujarat, seeks a Quality Assurance professional to ensure GMP compliance across validation, change control, documentation, and training in an API manufacturing environment.

You will oversee data management, batch documentation control, change control processes, and qualification activities, ensuring data integrity and alignment with regulatory requirements.

Qualifications

• MSc in Chemistry
• 5–6 years of pharma API experience
• Experience with GMP systems and regulatory requirements

Responsibilities

• Data Management Analysis: collect, compile, analyze, and review data related to manufacturing, testing, sourcing, deviations, stability studies, and change controls to support and maintain validated product status.
• Batch Documentation Control: manage and ensure the controlled issuance of BMRs and related documentation, including batch numbers and issuance to operations.
• Change Control Management: oversee initiation, impact assessment, review, approval, implementation, and closure of changes related to GMP systems and operations.
• Validation Qualification Oversight: review and approve validation protocols, reports, and qualification documents for GMP equipment, instruments, processes, cleaning, and computerized systems.
• GMP Documentation Management: manage GMP docs through generation, revision, review, approval, issuance, control, and archival processes.
• Quality Metrics Reporting: track, trend, analyze, and report quality metrics for management reviews.
• Regulatory Support: provide quality systems support to regulatory affairs regarding submissions and post-approval changes.
• Training Audit Programs: manage GMP training programs, qualifications, audits, and internal inspections.
• Computerized Systems Compliance: review lifecycle docs for GMP systems and ensure data integrity.

Skills

Data analysis

Batch docs

Change control

Validation oversight

GMP docs

Quality metrics

Regulatory support

Training programs

CS compliance

Education

MSc in Chemistry

Job description

Job Description

Purpose of the Job

To ensure compliance of Quality Systems with GMP, regulatory, and corporate requirements through effective management of validation, change control, documentation, qualification, training, quality metrics, audits, and continuous improvement activities. The role provides quality oversight and support to manufacturing, laboratory, engineering, and regulatory functions to maintain product quality, data integrity, and regulatory compliance in an API manufacturing environment.

Key Responsibilities

• Data Management Analysis: Collect, compile, analyze, and review data related to manufacturing, testing, sourcing, deviations, stability studies, and change controls to support and maintain the validated status of products.
• Batch Documentation Control: Manage and ensure the controlled issuance of Batch Manufacturing Records (BMRs) and related documentation, including assignment of batch numbers and issuance to operations for execution.
• Change Control Management: Oversee the Change Control process, including initiation, impact assessment, review, approval, implementation, and closure of changes related to GMP systems and operations.
• Validation Qualification Oversight: Review and approve validation protocols, reports, and qualification documentation associated with GMP equipment, laboratory instruments, processes, cleaning activities, and computerized systems
• GMP Documentation Management: Manage GMP documentation through generation, revision, review, approval, issuance, control, and archival processes, including the Validation Master Plan (VMP).
• Quality Metrics Reporting: Track, trend, analyze, and report Quality Metrics for site management reviews and continuous improvement initiatives.
• Compliance Continuous Improvement: Perform regulatory and quality compliance assessments, gap analyses, SOP development, and monitoring of CAPA effectiveness.
• Regulatory Support: Provide Quality Systems support to Regulatory Affairs regarding regulatory submissions, market authorizations, and post-approval changes.
• Training Audit Programs: Manage GMP training programs, personnel qualification activities, Quality Gemba Walks, self-inspections, and internal audits as per approved procedures.
• Computerized Systems Compliance: Review and approve lifecycle documentation associated with GMP computerized systems and ensure data integrity compliance. Qualifications

Qualification

Msc- Chemistry

Experience Required

5-6 Years in Pharma API