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Job Title: Senior Specialist Quality Assurance – Large Molecule Manufacturing Plant
Job Description
We are seeking a highly skilled Senior Specialist in Quality Assurance to support a technical team interfacing between our company and External Partners in Biologics Drug Substance and Drug Product Manufacturing. This role will ensure compliance with quality assurance processes and regulatory standards during technical transfers and throughout commercial manufacturing at External Partner sites.
Key Responsibilities
- Quality Oversight: Provide direction on quality objectives and ensure oversight of all quality-related issues at External Partner sites.
- Regulatory Compliance: Ensure all quality assurance activities comply with FDA, EMA, and internal regulatory requirements during facility start-up and technical transfers.
- Manufacturing Support: Offer continuous quality support by resolving quality issues, analyzing process performance, and developing compliance plans.
- Collaboration: Work with Biologics Quality Operations and relevant teams to address quality-related concerns and ensure smooth product lifecycle management.
- Validation Strategies: Support and oversee validation processes for new and existing products to maintain quality compliance.
- Technical Review: Assess process change requests, deviations, protocols, and Master Batch Record changes to ensure alignment with quality standards.
- Issue Resolution: Troubleshoot quality-related manufacturing issues and conduct investigations using scientific methodologies.
- Efficiency Improvement: Develop and implement efficient regulatory compliance methods without compromising quality standards.
- Quality Management System: Maintain adherence to quality, compliance, and safety standards by complying with Manufacturing Division Quality Management System requirements.
- Partner Engagement: Foster a culture of quality and compliance by collaborating with External Partners to achieve business objectives.
Candidate Profile
Education Requirements:
- Bachelor’s or Master’s degree in Chemical/Biochemical Engineering, Biotechnology, Microbiology, Pharmaceutical Science, Life Sciences, or a related field.
Required Experience and Skills:
- Minimum 15 years of experience in quality assurance within biopharmaceutical operations, particularly in Drug Substance and Drug Product Manufacturing and Validation.
- Strong expertise in quality systems, regulatory compliance, and quality assurance practices in the biopharmaceutical industry.
- Experience with change management processes and regulatory support planning.
- Proven knowledge in process validations, cleaning validations, analytical testing, in-process controls, and batch record reviews.
- Ability to conduct risk assessments and implement continuous improvement strategies.
- Proficiency in computer system validations, equipment validations, audits, and batch release procedures.
- Strong communication skills for managing external partnerships and addressing quality concerns.
Preferred Experience and Skills:
- Familiarity with high-performance organizational tools and digital manufacturing processes in biologics production.
- Hands-on experience with quality management software and performance metrics analysis.
Additional Information
- Experience: 5+ years
- Qualification: M.Pharm, B.Pharm, M.Sc, B.Sc
- Location: Hyderabad, Telangana, India
- Industry Type: Pharma/ Healthcare/ Clinical Research
- Functional Area: QA, Large Molecule
- Requisition ID: R341564
- End Date: 25-04-2025
Join us in making a difference by ensuring the highest standards of quality in biologics manufacturing! Apply now.
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