CSV & CQV

Lead Validation Engineer

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.

Location

Hyderabad, India (Onsite)

Type

Full-time · 55 hrs / week

Level

Lead

Experience

7+ years

About the role

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.

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