01
TRPD-26-04274
GMP/QMS Lead
GMP/QMS Lead responsible for ensuring end-to-end cGMP and QMS compliance across project phases, including documentation control, validation/qualification (DQ/IQ/OQ/PQ), risk management, and regulatory inspection readiness. The role drives 21 CFR Part 11 and ALCOA++ compliant documentation, coordinates validation for engineering systems/equipment (including HVAC and GxP computerized/automation systems like PLC/DCS), authors/updates SOPs, and partners with QA/QC/Production/Engineering to ensure classified area practices, hygiene, and site execution quality.
Position summary
- Location
- India
- Workplace
- On-site
- Employment
- Full Time
- Experience
- Minimum 10 years and Maximum 20 years
Role overview
Why This Role Matters.
GMP/QMS Lead responsible for ensuring end-to-end cGMP and QMS compliance across project phases, including documentation control, validation/qualification (DQ/IQ/OQ/PQ), risk management, and regulatory inspection readiness. The role drives 21 CFR Part 11 and ALCOA++ compliant documentation, coordinates validation for engineering systems/equipment (including HVAC and GxP computerized/automation systems like PLC/DCS), authors/updates SOPs, and partners with QA/QC/Production/Engineering to ensure classified area practices, hygiene, and site execution quality.
Your Impact
Deliver Enterprise Value
Help organisations solve complex business problems through modern technology, consulting expertise and measurable outcomes.
Collaboration
Work Across Teams
Collaborate with consultants, architects, engineers and client stakeholders throughout the project lifecycle.
Growth
Learn Continuously
Gain exposure to enterprise technologies, certifications, mentoring and real-world project experience.
Career Path
Grow With Ubique
Build a long-term consulting career with opportunities to take on greater responsibility and leadership over time.
Responsibilities
What You'll Be Doing.
Every role at Ubique contributes directly to solving meaningful business challenges for our clients.
02
All activities related to GMP/QMS documentation and site execution work (as and when required), including but not limited to the following points
03
Ensure adherence to cGMP guidelines and 21 CFR Part 11 compliance.
04
Maintain online documentation following ALCOA++ principles.
05
Prepare and review equipment layout plans, URS, DQ/IQ/OQ/PQ documents.
06
Coordinate validation activities for engineering systems and equipment.
07
Draft and update Standard Operating Procedures (SOPs) for operation, maintenance, and engineering activities.
08
Liaise with QA, QC, Production, and Engineering teams for smooth operations.
09
Ensure compliance with classified area practices (e.g., HVAC, pressure differentials, cleaning protocols).
10
Maintain cleanliness and hygiene of process and service areas as per SOPs.
11
Support in Qualification of all third-party PLC, DCS & field instruments systems as per GXP system (21 CFR part 11)
12
Ensure all material entry inwards and outwards certification and reconciliation on monthly basis
Technology stack
Tools & Technologies.
The platforms and technologies you'll use to build modern, enterprise-grade solutions.
01
cGMP
Required
02
QMS
Required
03
GDP
Required
04
GxP
Required
05
21 CFR Part 11
Required
06
ALCOA++
Required
07
data integrity
Required
08
URS
Required
09
DQ
Required
10
IQ
Required
11
OQ
Required
12
PQ
Required
13
validation
Required
14
qualification
Required
15
HVAC validation
Required
16
classified areas
Required
17
pressure differentials
Required
18
cleaning validation
Required
19
SOP
Required
20
risk assessment
Required
Requirements
Skills & Experience.
We value curiosity, collaboration and continuous learning. If you don't meet every requirement but believe you can make an impact, we'd still love to hear from you.
Essential
Required Qualifications
cGMP compliance
QMS documentation and documentation control
21 CFR Part 11 compliance (GxP data integrity)
ALCOA++ principles (data integrity)
Validation/qualification documentation (URS, DQ, IQ, OQ, PQ)
Risk assessment and risk management across project phases
SOP drafting and updating (operations/maintenance/engineering)
Coordination with QA/QC/Production/Engineering stakeholders
Classified area practices (HVAC, pressure differentials, cleaning protocols)
Pharma background
Knowledge of GDP and safety norms
Ability to read construction drawings/specifications and extract BOQs
Management of construction drawings and control of superseded/obsolete drawings
Preferred
Nice to Have
HVAC validation documentation
Qualification support for PLC/DCS/field instruments as GxP systems
Regulatory inspection support/inspection readiness
Material inward/outward certification and monthly reconciliation
Gap assessment in basic and detailed design and change suggestions
Knowledge/oversight of IGBC requirements and documentation
Project reporting (fortnightly progress reporting)
Planning accuracy/tolerance awareness (+/-5%)
Hindi and English communication
What you'll gain
More Than Just A Job.
We're committed to helping every team member grow professionally, personally and technically while working on meaningful projects.
Global Exposure
Collaborate with international clients and multicultural teams on enterprise programmes.
Continuous Learning
Expand your expertise through mentoring, certifications and hands-on project experience.
Career Growth
Take ownership, develop leadership skills and grow your consulting career over time.
Flexible Working
Hybrid and remote collaboration designed around trust and delivering exceptional outcomes.
People First
Join a supportive culture where collaboration, respect and long-term relationships come first.
Enterprise Projects
Work on meaningful technology initiatives for leading organisations across industries.
Apply
Apply for GMP/QMS Lead
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