Lead Validation Engineer

Qualify IT Solutions; Hyderabad; On-site; INR 1,800,000 - 2,800,000; Full time

Benefits offered by this job

PMP or Six Sigma certification

FDA/EMA inspections experience

Job summary

Qualify IT Solutions in Hyderabad, India seeks a Lead Validation Engineer to spearhead QMS development, validation strategy and gxp-compliant audits in a highly regulated pharmaceutical services setting.

You will mentor a team of validation engineers, oversee CSV/CQV activities and manage change controls, ensuring ALCOA++ data integrity and regulatory alignment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry or related field.
• 7+ years of professional experience in pharmaceutical validation, quality assurance or GMP compliance.
• Proven expertise in CSV, CQV, IQ/OQ/PQ and GAMP 5 methodologies.
• In-depth knowledge of FDA, EMA, ICH, WHO guidelines and regulatory requirements.
• Strong leadership and team management capabilities.
• Experience with validation documentation, ALCOA++ principles and data integrity.
• Proficiency in MS Office, QMS software and preferably ERP systems.

Responsibilities

• Lead development, implementation and continuous improvement of QMS across offerings.
• Drive validation strategy, audits, CAPAs and team mentorship in a regulated environment.
• Oversee lifecycle management of GxP documentation and change controls.
• Act as primary contact for client audits and regulatory inspections.
• Prepare and execute CSV & CQV protocols and reports.
• Own protocol, equipment/instrument and deviation numbering; ensure archival.
• Lead Quality Risk Management activities and mitigate compliance risks.
• Represent validation during inspections; conduct gap assessments and mock audits.
• Lead a team of validation engineers/associates or coordinate contractors.
• Deliver GxP and quality compliance training programs.

Skills

Leadership

CSV/CQV

IQ/OQ/PQ

GAMP 5

Regulatory knowledge

Data integrity (ALCOA++)

Audits & inspections

MS Office

QMS software

ERP systems

Education

Bachelor's degree in Engineering, Life Sciences, Chemistry or related

Tools

MS Office

QMS software

ERP systems

Job description

Lead the development, implementation and continuous improvement of Quality Management Systems across pharmaceutical service offerings. Drive validation strategy, audits, CAPAs and team mentorship in a highly regulated environment.

Lead the development, implementation and continuous improvement of Quality Management Systems across pharmaceutical service offerings. Drive validation strategy, audits, CAPAs and team mentorship in a highly regulated environment.

Responsibilities

• Lead the development, implementation and continuous improvement of the QMS aligned with cGMP, GLP, GCP, GVP, GxP, ICH, FDA, EMA and WHO regulations.
• Oversee lifecycle management of GxP documentation — SOPs, policies, work instructions and quality records (deviations, CAPAs, change controls, OOS, OOT).
• Develop and execute a risk-based annual internal audit plan; lead audits, prepare reports and drive CAPA implementation and effectiveness verification.
• Act as primary contact for client audits and regulatory inspections (FDA, EMA, local authorities); support supplier qualification and audits.
• Prepare, review and execute CSV & CQV — VMP, SLIA, GAP Assessment, URS, DQ, FAT, SAT, IQ, OQ, PQ protocols and reports.
• Own document protocol, equipment/instrument, change control and deviation numbering; ensure validation data archival and moment register upkeep.
• Lead Quality Risk Management (QRM) activities and proactively mitigate quality and compliance risks.
• Represent the validation function during internal, external and regulatory inspections; conduct gap assessments and mock audits.
• Lead a team of validation engineers/associates or coordinate third-party contractors — assign tasks, monitor performance and mentor on GMP compliance.
• Deliver GxP and quality compliance training programs; establish qualification programs for validation personnel.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Chemistry or related discipline.
• Minimum 7+ years of professional experience in pharmaceutical validation, quality assurance or GMP compliance.
• Proven expertise in CSV, CQV, IQ/OQ/PQ and GAMP 5 methodologies.
• In-depth knowledge of FDA, EMA, ICH, WHO guidelines and regulatory requirements.
• Strong leadership and team management capabilities.
• Experience with validation documentation, ALCOA++ principles and data integrity.
• Proficiency in MS Office, QMS software and preferably ERP systems.

Nice to have

• PMP or Six Sigma certification.
• Prior experience hosting FDA / EMA regulatory inspections.

Lead Validation Engineer