Am - Quality Assurance (Pharmaceuticals)

2 months ago

Ankleshwar, India Zentiva Group, a.s. Full time

Education:
Graduate / Post Graduate in Pharmacy or Chemistry

**Experience**:
07-08 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements

Quality Management/Continuous Improvement

Handling of Deviations & CAPA

Handling of Product Technical Complaints

Review of Master Batch Manufacturing & Packing Records

Release / rejection of Finished Products

Management and Control of Documents, such as SOPs, Master Documents

Issuance of BMR/BPR, log books and other controlled documents

Management of Documentation room

Preparing & review the Annual Product Quality Review

Batch Rework/Reprocessing (Coordination from QA point of view)

Coordination of cGMP Training activity including training of the people

Handling of returned goods (Coordination from QA point of view)

Handling of Self inspections

Compliance to EN ISO 13485 requirements

Validations & Qualifications:
Preparation of Validation Master Plan

Ensure validated status of all equipment, manufacturing processes, and cleaning processes

Review of validation plans for facility / utilities / equipment / instrument / process / computer / cleaning

Review of protocols for qualification and validation of facility/ equipment / product / process

Review and certification of validation reports after execution of validation of facility /equipment / product / process

Sampling activity for validation batches

Compliance:
Ensure adherence to company Quality Standards, EU regulations and Local FDA regulations, by

understanding the requirements

Performing the Gap analysis to find out the gaps in existing system

Preparing a compliance plan for closure of gaps

Execution of compliance plans

Review of completion of compliance activity

Prepare for and attend to external / regulatory Quality audits

Assuring quality of products by:
Ensuring SOP review and compliance

Management of Events

Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure

Investigation of deviations & Customer complaints

Review of executed Batch Manufacturing & Packing Records

Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints

Ensuring the effectiveness review of the implemented CAPA

To approve the line clearance in manufacturing & Packing

cGMP Training:
To develop training modules and organize training in GMP

Develop and execute the overall training program in coordination with all concerned departments

Other:
Implementing the pest control program as and when required

Review of maintenance and calibration program and calibration documents

Review of quality control documents

Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
- External Job Description

External Job Description

**Education**:
Graduate / Post Graduate in Pharmacy or Chemistry

**Experience**:
07-08 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements

Quality Management/Continuous Improvement

Handling of Deviations & CAPA

Handling of Product Technical Complaints

Review of Master Batch Manufacturing & Packing Records

Release / rejection of Finished Products

Management and Control of Documents, such as SOPs, Master Documents

Issuance of BMR/BPR, log books and other controlled documents

Management of Documentation room

Preparing & review the Annual Product Quality Review

Batch Rework/Reprocessing (Coordination from QA point of view)

Coordination of cGMP Training activity including training of the people

Handling of returned goods (Coordination from QA point of view)

Handling of Self inspections

Compliance to EN ISO 13485 requirements

Validations & Qualifications:
Preparation of Validation Master Plan

Ensure validated status of all equipment, manufacturing processes, and cleaning processes

Review of validation plans for facility / utilities / equipment / instrument / process / computer / cleaning

Review of protocols for qualification and validation of facility/ equipment / product / process

Review and certification of validation reports after execution of validation of facility /equipment / product / process

Sampling activity for validation batches

Compliance:
Ensure adherence to company Quality Standards, EU regulations and Local FDA regulations, by

understanding the requirements

Performing the Gap analysis to find out the gaps in existing system

Preparing a compliance plan for closure of gaps

Execution of compliance plans

Review of completion of compliance activity

Prepare for and attend to external / regulatory Quality audits

Assuring quality of products by:
Ensuring SOP review and compliance

Management of Events

Controlling the changes made to facility / equipment / product / process an

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