Qa Executive

Position Title:

• Executive/Senior Executive Quality assurance (Batch Record Review & Release)

Department:

• Quality Assurance

Location:

• Hyderabad (Company based in UK)

Reports To:

• Sr. Quality Manager & RP

Company Overview:

• Our company is a UK-based pharmaceutical organisation engaged in Manufacturing and Import Authorisation (MIA) and Wholesale Distribution Authorisation (WDA) activities. We specialise in the manufacture, import, and distribution of pharmaceutical products in compliance with MHRA and EU GMP standards.
• We work in close collaboration with Contract Manufacturing Organisations (CMOs), suppliers, and other partners to ensure the highest standards of product quality, safety, and regulatory compliance across our supply chain.

Position Summary:

• Executive / Senior Executive – Quality Assurance is responsible for the review of executed Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), and associated production and quality documents to ensure compliance with Dossier, cGMP, SOPs, and regulatory requirements. The role involves batch disposition and release activities while coordinating with CMOs and other cross-functional teams to ensure timely product release. Experience in preparing and reviewing batch documentation packages and supporting Qualified Person (QP) batch certification activities.

Key Responsibilities:

• Review executed Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), and all associated production documents for completeness, accuracy, and GMP compliance.
• Perform detailed batch record review to verify compliance with approved Master Batch Records, approved dossiers, SOPs, and regulatory requirements.
• Ensure all in-process controls, manufacturing parameters, and packaging activities are

accurately documented.

• Review deviations, investigations, OOS/OOT, change controls, and CAPAs related to batch release activities.
• Verify completion of all quality documentation before batch disposition.
• Perform batch release activities after ensuring compliance with all quality requirements.
• Ensure compliance with current approved dossier requirements.
• Support internal audits and regulatory inspections.
• Assist in investigation of market complaints, product quality issues, and implementation of CAPAs.
• Support continuous improvement initiatives to enhance quality systems and reduce documentation errors.
• Ensure adherence to safety, quality, and regulatory requirements throughout the documentation.

Core Competencies:

• Strong knowledge of pharmaceutical manufacturing operations.
• Excellent understanding of cGMP requirements and regulatory guidelines.
• Strong documentation review and analytical skills.
• Attention to detail with the ability to identify documentation discrepancies.
• Good communication and coordination skills.
• Effective problem-solving and decision-making abilities.
• Ability to work under timelines while maintaining compliance.
• Commitment to quality, compliance, and continuous improvement.

Education & Qualifications:

• Bachelor’s or master’s degree in pharmacy, Life Sciences.
• Strong understanding of pharmaceutical manufacturing and distribution processes.
• In-depth knowledge of EU GMP, GDP, MHRA, and other relevant regulatory frameworks.

Experience Required:

• 5 -6 year of relevant experience within Pharmaceutical Plant Quality Assurance.
• Hands-on experience in Executed Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) Review.
• Experience in Batch Release and Batch Disposition activities.
• Good exposure to Production documentation review and cGMP compliance.

Why Join Us:

• Work with a UK-based pharmaceutical company.
• Gain exposure to global quality and compliance operations.
• Be part of a dynamic, collaborative team driving continuous improvement.