Executive/Sr. Executive - Quality Assurance

Designation : Executive/Sr. Executive

Department: Quality Assurance

Required Experience: 5-10 years

IPQA DS

Role & responsibilities

• Develop and execute IPQA strategy aligned with overall quality objectives.
• Lead and mentor the IPQA team.
• Ensure compliance with regulatory standards and internal SOPs.
• Analyze in-process quality data to drive process improvements.
• Manage audits, inspections, and regulatory submissions related to in-process quality.
• Verification of calibration of equipment used in manufacturing activity
• Ensure sampling of respective stages as per batch records and specification.
• Ensure process validation and cleaning validation sampling and submission of sampled to QC lab.

IPQA DP

Role & responsibilities

• Develop and execute IPQA strategy aligned with overall quality objectives.
• Ensure area clearance as per SOP for fill-finish and packing section.
• Ensure sampling of all the stages as per BMR and specification
• Ensure compliance with regulatory standards and internal SOPs.
• Analyze in-process quality data to drive process improvements.
• Participation and review of investigations related to market complaints and process related deviation.
• Submission of samples to QC related to finished product, process validation and cleaning validation.
• Designing of validation protocols for visual inspection and execution of activity.

QMS

Role & responsibilities

• Handling of QMS e-modules,
• Handling of change control, deviations, CAPA and QRM.
• Support deviation investigations and CAPA implementation.
• Coordinate with production and QA teams for quality improvements.
• Review of master and executed documents for the compliance to actions defined in QMS.
• Preparation of SOP's related to governance (system)
• Preparation of APQRs
• Preparation of trends of QMS modules.
• Tracking of action items for its implementation on time.
• Participation and handling of investigations.

Please share your resume at [email removed]