QA - Validation & Equipment Qualification

Kopran

3 - 4 years

3 - 4 Lacs

khopoli

Posted:4 hours ago| Platform:

Apply

Skills Required

granulation tablets formulation osd solid orals liquid orals capsules tablet coating rmg

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Plan, execute, and review
Validation Protocols and Reports
(Process, Cleaning, Analytical Method, and Computer System Validation).
Execute and review
Equipment Qualification activities
(IQ/OQ/PQ, Re-qualification).
Support preparation and maintenance of
Validation Master Plan (VMP)
.
Ensure compliance with cGMP, FDA, MHRA, WHO, and other international regulatory guidelines.
Coordinate with cross-functional teams (Production, Engineering, QC, R&D) for smooth execution of validation activities.
Conduct
risk assessments
and gap analysis for equipment, utilities, and processes.
Review and maintain
SOPs, protocols, and technical documentation
related to validation.
Handle deviations, CAPA, and change controls related to validation/qualification.
Participate in internal and external audits, providing necessary validation and qualification documents.
Ensure timely execution of periodic
re-validation and re-qualification activities
.

Preferred candidate profile

Strong knowledge of
cGMP, ICH, FDA, and other regulatory guidelines
.
Hands-on experience in
equipment qualification (IQ/OQ/PQ)
.
Good understanding of
cleaning validation, process validation, and computerized system validation
.
Strong documentation and technical writing skills.
Excellent analytical, problem-solving, and communication skills.
Ability to work collaboratively in cross-functional teams.

More Jobs at Kopran

Executive / Asst. Manager - Regulatory Affairs (API)

Mumbai, Mumbai Suburban, Mumbai (All Areas)

6.0 - 8.0 yrs

INR 6 - 10 Lacs

Officer - Logistics - APIs

Mumbai, Mumbai Suburban, Mumbai (All Areas)

Experience: Not specified

INR 2 - 3 Lacs

Purchase Officer

Mumbai, Mumbai Suburban, Mumbai (All Areas)

Experience: Not specified

INR 2 - 3 Lacs

Senior Manager - Regulatory Affairs (Formulations)

Mumbai, Mumbai Suburban

10.0 - 20.0 yrs

INR 15 - 30 Lacs

Store Manager - Formulation

Khopoli

10.0 - 15.0 yrs

INR 10 - 15 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.