QA Specialist

Overview

QA Specialist responsible for quality lifecycle management of an assigned subcontracted product portfolio and independent Quality Assurance oversight of products and suppliers.

What you'll do

• Manage routine deviations, complaints and related CAPAs.
• Conduct root cause analysis and follow up corrective and preventive actions.
• Review change controls, GMP documentation, analytical data and batch records.
• Support batch release decisions and review PQRs and stability data.
• Conduct quality risk assessments and review qualification and validation documents.
• Prepare for and participate in supplier audits, internal audits and inspections.
• Manage supplier quality discussions, agreements, databases and QMS activities.

What you'll need

• University degree in Pharmacy, Chemistry, Biology or a relevant Life Science.
• At least 5 years of relevant Quality Assurance or GMP-regulated experience.
• Strong knowledge of GMP and understanding of ICH and pharmaceutical regulatory requirements.
• Experience with deviations, CAPA, root cause analysis, change control and quality risk management.
• Experience reviewing GMP, analytical, stability and quality documentation.
• Strong communication, negotiation, analytical and problem-solving skills.
• Advanced English and good knowledge of relevant IT and quality systems.

Nice to have

• Experience with supplier quality management and audits.

Details

• Location: Ankleshwar, India.