Executive

Profile Summary:

Quality assurance play a crucial role in business by ensuring that products meet certain thresholds of acceptability. They plan, direct or coordinate quality assurance programs and formulate quality control policies. They also work to improve an organization’s efficiency and profitability by reducing waste.

Expected Qualification

A Bachelor’s or Master’s degree in Chemistry /Pharmacy.

Expected number of Years of Experience

4-7 years

Roles and Responsibilities

• To manage the proper functioning of quality assurance with continuous support and co-operate to other areas of the plant in cGMP norms implementation with regulatory & Statutory compliance.
• To highlight quality related problems in time, seek the readdressed and contribute in troubleshooting.
• Final batch release.
• To evaluate batch records.
• To plan and monitor the routine functions of all the areas of QA (IPQA, validation, documentation).
• Review and approval of change control.
• To participate in investigation of deviation.
• Review and training of Sop’s.
• To ensure that the required initial and continuing training of quality department personnel is carried out and adapted according to need.
• Review of calibration reports.
• Preparation of products quality review.
• In process control monitoring.
• Handling of Returned products.
• Internal Quality Audits and their execution to ensure compliance to cGMP.
• To handle external audits and fulfilling their corrective and preventive action within a specified period of time.
• Final checking of material physically and also cross verification of weight during each dispatch.
• Final checking of COA’s and packing list during each dispatch

Skills Required

Strong problem-solving, critical thinking, and analytical skills.
Good presentation, documentation, and reporting skills.
Good verbal and written communication skills.
Strong technical skills.