QA Specialist (CQV)

India, Hyderabad

QA Qualification Specialist

Location: Hyderabad, India

Job Description Summary:

As a QA Qualification Specialist, you will be responsible for supporting, reviewing, and approving qualification documentation for facilities, utilities, computerized systems, and equipment in accordance with GMP requirements, Lonza standards, and governance. You will collaborate with site quality teams to enable operational performance, ensure technical consistency, and deliver compliant documentation. This role also provides oversight into validation and technical service activities, including process and cleaning procedures, ensuring audit readiness and regulatory compliance.

Key Responsibilities

• Commissioning & Qualification Lifecycle: Review and approve reports, protocols, and test documentation for commissioning and qualification of facilities, utilities, computerized systems, equipment, and laboratories in line with Lonza standards and regulatory expectations.

• GMP Design Review: Support the review of GMP design deliverables (flows, zoning, layouts) to ensure compliance.

• Deviation Management: Ensure discrepancies or deviations related to facilities and utilities are assessed, documented, traceable, and resolved.

• Periodic Requalification & Validation Maintenance: Review and approve periodic requalification documentation (e.g., freezers, autoclaves, HVAC, biosafety cabinets, cold rooms). Confirm validated state through validation maintenance reports. Review and approve decommissioning documentation as applicable.

• Quality & Risk Management: Review and support management of quality records (deviations, CAPA, change controls, investigations, product quality review). Maintain high standards of GMP compliance, documentation quality, and technical accuracy.

• Audit Readiness: Promote and maintain a state of audit readiness across qualification activities.

• Timely Delivery: Ensure assigned work is delivered within agreed timelines, proactively identifying and escalating risks or delays.

• Continuous Improvement: Contribute to process improvement initiatives and support implementation of new tools or approaches.

• Other Duties: Perform additional quality and compliance tasks as assigned.

Education & Experience

• Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, or related scientific field.

• Minimum 5 years of relevant experience in regulated pharmaceutical industry (engineering, manufacturing, QA, QC).

• Experience in commissioning, qualification, and validation of manufacturing equipment, facilities, utilities, support systems, laboratory equipment, and computerized systems.

• Experience in process or cleaning validation beneficial.

• Proven experience in EMA/FDA regulated environments with strong knowledge of ICH, PIC/S, EU, and US regulatory requirements.

• Experience in chemical and biological GMP API manufacturing with ability to interpret and implement quality and regulatory requirements.

• Knowledge of CQV approaches and electronic validation tools (e.g., Kneat Gx).

Skills & Attributes:

• Strong analytical and problem-solving skills.

• Ability to communicate effectively in an international environment.

• Self-starter, solution-driven, and team player.

• Experience with process mapping and performance analysis desirable.

• Strong PC and software skills, especially Microsoft Office; Power BI experience a plus.

• Excellent spoken and written English; German desirable.

Competencies & Behaviors

• Agility: Learns from experience, adapts to change, supports process improvement, and embraces new approaches.

• Business Acumen: Understands corporate strategy, makes accurate and timely decisions, and identifies improvements.

• Collaboration: Shares knowledge generously, balances listening and speaking, and treats colleagues with respect.

• Customer Focus: Understands customer needs, responds to feedback, and enhances satisfaction.

• Driving Results: Delivers goals consistently, maintains quality standards, and organizes work to meet deadlines.

• Leadership: Takes responsibility for safety, personal choices, and behaviors; contributes to a positive work environment.

About Lonza

At Lonza, quality assurance is fundamental to ensuring compliance, reliability, and inspection readiness across our global operations. Our QA Qualification Specialists play a critical role in maintaining validated states of facilities, utilities, and systems, supporting audit readiness, and driving continuous improvement. Guided by our values—Collaboration, Accountability, Excellence, Passion, and Integrity—we foster innovation and compliance excellence. By joining Lonza, you will help shape the future of quality assurance and contribute to the medicines of tomorrow.