QA - Executive

Kopran

2 - 4 years

4 - 5 Lacs

Khopoli

Posted:3 hours ago| Platform:

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Skills Required

Gap Assessment Regulatory Guidelines CGMP PQ OQ Formulation Csv IQ

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Execute and review
Equipment Qualification protocols (IQ, OQ, PQ)
in compliance with regulatory requirements.
Prepare, execute, and review
Cleaning Validation protocols and reports
.
Participate in the design, execution, and documentation of
Computer System Validation (CSV)
as per GAMP 5 guidelines.
Coordinate and support
Process Validation
activities, including preparation and review of protocols, execution, and final reporting.
Ensure that all validation activities are compliant with
cGMP, regulatory guidelines
, and internal SOPs.
Perform
gap assessments, risk assessments
, and deviation handling related to validation.
Collaborate with cross-functional teams including production, engineering, QC, and IT for validation planning and execution.
Assist in
internal audits, regulatory inspections
, and prepare responses to audit observations.
Maintain and update validation master plans and SOPs regularly.

Skills & Competencies

B. Pharm
/ M. Pharm / M.Sc.
in relevant field.
Minimum
4 years of hands-on experience
in QA validation functions in a regulated pharmaceutical manufacturing environment.
Strong understanding of
equipment and utility qualification, cleaning validation, CSV, and process validation
.
Familiar with guidelines such as
GAMP 5, 21 CFR Part 11, ICH Q8-Q10
, and applicable regulatory standards.
Good documentation and analytical skills.
Proficient in
MS Office
, knowledge of QMS software is an advantage.
Strong communication and coordination skills.

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