Executive - Quality Control, Pharma

Job Title: Executive Quality Control Pharma, (For Stability section)

Qualification: M. Sc (Organic Chemistry) with 3 to 5 years of experience in Pharmaceutical Quality control in the stability section.

Candidate with sound experience in the Pharma formulation in quality control in the stability section.

Specific Requirements:

Experience in Solid Dosage Form (Tablets).

Worked with EU regulatory-approved or USFDA.

Quality Control (Stability section).

Operating SAP and QMS tools (eDMS, Quality forward)

Compilation and Documentation of Pharmaceutical documents.

Communication, coordination, and Tracking.

Job Summary:

Handling of Qualification/Validation & Revalidation strategy protocol/Report & its related activities in the stability section.

Preparation of Stability study protocols and related documents with LIMS.

Preparation of stability analysis report and stability study report.

Provide support for investigation-related events/deviations/CAPAs.

Notify change requests & events to concerned departments.

Review guidelines, related to stability study.

Stability study planner preparation, monthly/yearly.

Maintaining and monitoring stability chambers, stability samples loading & withdrawal and related activities.

sample withdrawal as per planner. Sample collection for charging.

Labeling, storage, and charging of stability samples.

Handling discontinuation of stability studies with proper documentation and discarding.

Coordinate with Production/packing, warehouse, and QA/QC related to stability study.

Maintenance and review of log book related to stability study.

Preparation of SOPs, Formats, and related documents for stability study.

Preparation of calibration schedule.

Handling of change control, OOS, deviation, and Incidents.