Job Description
Purpose
To perform IPQA activities, ensure compliance with cGMP requirements, oversee shop floor QA operations, and review batch records for timely product release.
Position / Job Title
QA Officer
Department
QA - IPQA
Reporting To
Section head
Location
Satara
Years Of Experience
Years of Experience 5–7 years of experience in pharmaceutical Quality Assurance, with exposure to IPQA and team handling
Dosage Form
Liquid (core area); experience in other dosage forms will be an added advantage.
Job Responsibilities / Deliverables
Plan and allocate IPQA manpower across shifts and production areas to ensure adequate coverage
Supervise and monitor IPQA officers for effective execution of shop floor activities
Review and verify IPQA observations, logbooks, and checklists for completeness and accuracy
Ensure uniform implementation of SOPs and GMP practices across all shifts
Provide guidance, on-the-job training, and mentoring to IPQA team members
Perform second-level review of critical documents and escalation of quality issues
Ensure timely closure of deviations, CAPAs, and compliance actions related to IPQA
Act as a point of contact during audits for IPQA-related activities
Drive continuous improvement initiatives and strengthen shop floor compliance culture
Shop Floor IPQA Activities (Individual Role)
Conduct in-process checks (IPQC) and proof checking during manufacturing and packing operations
Carry out pack line inspection and sampling of bulk finished and finished products
Perform sampling and execution support for process validation and cleaning
validation activities
Monitor shop floor through QA rounds and identify/report discrepancies or non- compliance
Verify dispensing activities for compliance with BMR/BPR Ensure GDP compliance on the shop floor
Issue, review, and reconcile BMR/BPR
Review of master batch records
Ensure completeness of batch release documentation and support archival
Identify, report, and initiate deviations observed during shop floor activities
Support investigation and CAPA implementation
Qualifications & Pre-Requisites
B. Pharm / M. Pharm With relevant experience in pharma quality assurance
Strong knowledge of IPQA activities, cGMP, and shop floor compliance
Experience in handling teams or acting as shift in-charge preferred
Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA.
Familiarity with Liquid Oral dosage forms and/or potent formulations, Sterile, Nasals, OSD (optional)
Strong communication, leadership, and coordination skills
Good understanding of GDP and Data Integrity requirements
Additional notes
Role is expected to work in all shifts and all days of the week.
Flexibility to take on additional responsibilities as assigned by management
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.
