Quality Assurance Officer

Sterling Healthcare; Maharashtra; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Sterling Healthcare in Talegaon, Pune, is seeking a Quality Assurance Officer to lead QA activities within the Quality Assurance department for formulation operations.

The role requires extensive QA/QC expertise with a strong focus on SOP preparation, document control, compliance with ICH guidelines, and maintaining calibration records, logbooks, and change-control processes.

Qualifications

• Minimum of 24 years of experience in quality assurance within the pharma industry
• B.Pharm. or M.Pharm degree required

Responsibilities

• Prepare quality assurance SOPs and ensure QA compliance by scheduling day-to-day activities.
• Review primary/working/reference standards and their management.
• Review system and equipment qualification records, calibration status and logbooks.
• Ensure proper storage of incoming samples according to defined conditions and log maintenance.
• Perform validations of computer systems used in QC instruments, production equipment and ERP systems.
• Identify and evaluate risk for equipment/instrument qualification and computer system validation per ICH Q9.
• Maintain stability study records and monitor stability chamber conditions.

Education

B.Pharm.

M.Pharm

Job description

Job Title Quality Assurance Officer

Department: Quality Assurance

Industry: Sterling Healthcare
Location: Talegaon, Pune
Function: Quality Control Formulation (OSD Plant)
Experience: 24 Years
Qualification: B.pharm. M Pharm

Role & responsibilities

• Preparation Of quality assurance sop
• To ensure the quality control compliances by scheduling the day to day activity.
• To review primary standard, working standard reference standard management.
• To review column management system
• To review system suitability solution record.
• To review chemical receipt and management record.
• To review logbooks.
• To ensure qualification record, calibration status and logbooks are properly maintained.
• To check random traceability of analysis performed by analyst.
• To ensure completeness training schedule of QC personnel.
• To perform validations of Computer system used in QC instruments, production equipment’s and ERP System, Spreadsheet etc.
• To identify And evaluate risk Assessment for equipment, instruments qualification and for validation of computer system as per ICH Q9 Guidelines.
• To update change regarding the equipment’s or instruments qualification and Computer system validation in csvmp.
• To identify the change Need in quality control procedure and assist to QC team regarding initiation of change control
• Charging withdraw of stability Samples as per the relevant stability protocol, master stability scheduled and stability monthly planner
• Preparation of stability protocol , master stability scheduled and stability monthly planner
• Maintain the stability chamber equipment’s usage log and reconciliation of stability samples.
• Maintain the stability study of finished product
• Daily monitoring and maintenance of temperature and relative humidity records of stability chambers
• Preventive maintenance and alarm verification of stability chambers.
• Review of long book and instruments/equipment's calibration report of quality control department.
• To ensure all incoming samples are stored as per the defined storage condition and log maintained.