Talent.com
enzene biosciences ltd
Senior Executive/Assistant Manager - US QAenzene biosciences ltd • Pune, India
Senior Executive/Assistant Manager - US QA

Senior Executive/Assistant Manager - US QA

enzene biosciences ltd • Pune, India
30+ days ago
Job description
Job Title: Sr. Executive / Assistant Manager – US QA Experience: 7–12 Years Qualification: M.Sc / M.Pharm Job Purpose

To provide Quality Assurance support to US-based manufacturing and quality operations , ensuring compliance with global cGMP, ICH, and regulatory requirements , with a strong focus on biosimilars . The role supports batch release, quality systems, validation, and continuous improvement initiatives in collaboration with global cross-functional teams.

Key Responsibilities US QA & Compliance

  • Provide QA oversight and support to US-based manufacturing and quality operations.
  • Ensure compliance with global cGMP, ICH, FDA , and applicable regulatory guidelines across QA activities.
  • Review and approve Batch Manufacturing Records (BMRs) and Certificates of Analysis (CoAs) .

Quality Systems & Investigations

  • Support and review deviation investigations, CAPAs, and change control activities; ensure timely closure in line with internal SOPs.
  • Participate in risk assessments , root cause analysis , and continuous improvement initiatives .
  • Contribute to the global harmonization of quality systems and SOPs .

Validation, Tech Transfer & Documentation

  • Provide QA guidance for technology transfers , process validation , qualification , and process improvement initiatives .
  • Review and approve SOPs, validation protocols, qualification documents , and other technical documentation.
  • Maintain electronic and paper-based documentation in compliance with ALCOA+ data integrity principles .

Quality Metrics & Reporting

  • Monitor and track key quality metrics and KPIs.
  • Prepare and present periodic quality reports for US leadership and stakeholders .

Cross-Functional Collaboration

  • Collaborate closely with Manufacturing, Quality Control, Regulatory Affairs, and R&D teams to ensure consistent quality standards.
  • Support regulatory inspections, audits, and responses as required for US operations.

Qualification:

  • M.Sc / M.Pharm (Mandatory)

Experience:

  • 7–12 years of QA experience in biologics / biosimilars

Technical Skills

  • Strong knowledge of cGMP, ICH, FDA regulations , and global quality standards
  • Hands-on experience in BMR & CoA review and approval
  • Expertise in deviations, CAPA, change control, and quality investigations
  • Experience in biosimilars manufacturing, validation, and tech transfer
  • Sound understanding of data integrity (ALCOA+) principles

Skills Required
deviations , quality investigations , Capa, Validation, Change Control, Cgmp, Ich, data integrity
Create a job alert for this search

Senior Executive/Assistant Manager - US QA • Pune, India

Similar jobs

Assistant Manager – Services Delivery

EmeritusPune, Maharashtra, India

About Emeritus: Emeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world.It ... Show more

 • Promoted

SENIOR QA ENGINEER (ISTQB)

Duncan & RossPune, Maharashtra, India
Quick Apply

Senior Individual Contributor (L4) | Reports to: Manual Lead / Architect.A senior individual contributor providing cross-application QA engineering depth.You will be the technical bridge between ma... Show more

Senior Manager -Operational Resilience

MashreqPune, Maharashtra, India

Job Purpose The job holder will support the implementation and ongoing maintenance of the Operational Resilience framework.Key Result Areas Reporting to the Head of Business Continuity and Operatio... Show more

 • Promoted

Senior Analyst

WNSPune (district), Pune (division); Maharashtra, IN

Partner closely with Valuation, Assumptions, Accounting Policy, Pricing and Risk Management teams in the development of sustainable annuity projection models, compliant with emerging accounting and... Show more

 • Promoted

Growth & Lead Generation Manager (Remote)

First Choice Business Debt SolutionsPune, Maharashtra, India
Remote

Company Description First Choice Business Debt Solutions is dedicated to helping small businesses, particularly Construction, Trade, and Trucking companies, overcome financial hardships caused by M... Show more

 • Promoted

Senior Project Director

Academian IncPune (district), Pune (division); Maharashtra, IN

We are looking for an experienced Sr.Director – PMO / Delivery Operations to lead large-scale EdTech delivery programs, operational governance, execution excellence, and cross-functional business d... Show more