Officer
Job Description
Purpose
To ensure timely execution of Equipment and Area Qualification activities and provide support in Process Validation, in compliance with cGMP and regulatory requirements.
Position / Job Title
Officer
Department
Quality Assurance
Reporting To
Section head-Qualification and validation
Location
Satara
Years of Experience
7+ years in Pharmaceutical Quality Assurance, with at least 3–4 years in equipment and area qualification and process validation.
Dosage Form
Liquid (core area); multi-dosage experience including tablet and sterile formulations will be an added advantage.
Job Responsibilities / Deliverables
Lead and manage qualification of equipment, utilities, and manufacturing areas in line with the Validation Master Plan.
Review qualification protocols and reports (DQ, IQ, OQ, PQ).
Ensure periodic requalification of facilities, utilities, and controlled environments.
Support process validation activities including preparation/review of validation protocols and reports.
Participate in risk assessments, change controls, and deviation/CAPA management related to qualification and validation.
Coordinate with Engineering, Production, QC, and RA for smooth execution of qualification and validation programs.
Ensure readiness of qualification and validation documentation for audits and inspections.
Provide training on qualification/validation requirements to QA and cross-functional teams.
Participate in internal audits, customer audits, and regulatory inspections.
Qualifications & Pre-Requisites
B. Pharm/ M. Pharm With relevant experience in pharma quality assurance.
Strong expertise in equipment and area qualification (DQ, IQ, OQ, PQ), computer system validation and understanding of process validation
Knowledge of utilities and cleanroom qualification requirements, GAMP 5.
Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA.
Strong documentation, problem-solving, and analytical skills.
Effective communication, Team coordination and work in collaboration within compliance
Additional notes
Role is expected to work in all shifts and all days of the week.
Will have to handle any other responsibility, if allocated.