Ensuring Quality of products as per specification. Approval of SOPs for all mfg. process.

Validation (as per ICH) of process, analytical methods, machines, air handling units, water, utility, cleaning processes. Mater validation plan. Revalidation in case of any changes

Risk analysis of process, method of all department.

Ensuring quality standards for all incoming material inspection like RM, PM, water, air, steam etc. pre-dispatch inspection and online inspection.

Internal Auditing of all departments as per schedule.

Handling customer, FDA, WHO, GMP, third party and Vendor Audit or any other audit.

Ensure implementation of all SOP with co ordination with concern dept. Customer co ordination and handling customer complaint.

Responsible for corrective and preventive action for customer complaint & other non-compliances, deviations and out of specification(oos). Root cause analysis of above.

Review and approve Calibration & validation of all measuring instruments & equipment/machines. Prepare annual product review and statistical trend analysis for the data. Informing any Non confirming of product/process to Management.

Review and approve of (BMR) Batch manufacturing records, Protocol for new products or review products.

Batch card issue & release and final product release. Reduce W.I.P Stocks goods in the shop floor. Ensuring that there is no (NC) noncompliance in any audits.

Training to Employee for on job training SOPs and Quality management system, GMPs, WHO standards.

Documentation of all Quality records. Ensure & monitor for House Keeping of plant and Inter. Dept. discipline (GMP)

Evaluating and approving change control for the specification and test method & Mfg. Process.

Review of water systems and trending.

Control of all documents like batch cards, MFR, BMR, and all related documents.

Preparation and maintenance of FDA related documents, product permission and certificates.

To represent company in FDA for all necessary compliances related work or public communication.

Carry out vendor audit as and when required. To check finished good products in BSR before dispatch. Calculation and verification of active raw material before manufacturing. Ensure & approve Online updating of BMR/ logbooks. Proper storage and retrieval of BMRs and other regulatory documents. Ensuring EHS standards to your working place. Responsible for co-ordination to customer regulatory, documentary requirements.

Organize and implement product inspection as per plans in QA department. (In-coming inspection and vendor site inspection)

Participation in safety committee meeting regularly. Maintaining discipline in department. Skills: roven experience as a quality assurance manager or relevant role Sound knowledge of quality assurance, outcomes measurement processes and methodologies

Excellent analytical and forecasting skills

Demonstrated capabilities in respect to data management, statistical reports and trend analysis and professional report preparation

Strong planning, coordination, and time management skills to effectively support regularly scheduled and targeted audit, program evaluation and service planning

Excellent writing skills to document, report and communicate findings Having experience of GMP & CGMP Audits Thorough knowledge of methodologies of quality assurance and standards. Excellent numerical skills and understanding of data analysis/statistical methods. Good knowledge of MS Office and databases.

Outstanding communication skills.

Great attention to detail and a result driven approach. Excellent organizational and leadership abilities. Reliable and Trustworthy. Experience in SAP system

Other Generic Skills:

Excellent technical (QA) skills

Problem-solving skills

Team working skills

IT skills

Sr. QA Manager

Job Description

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