7,384 Quality Director jobs in India
Director Quality Assurance
Posted 5 days ago
Job Viewed
Job Description
Core Job Responsibilities:
**1.** To make strategy and planning for Quality Assurance and Quality Control for smooth and effective functioning for ODF, LVP & Hormone block.
2. To strategize and plan for continual improvement of GMP aspects in the facility, systems, and procedures.
3. Budgeting for Capital expenses and Operating expenses. Plan and manage departmental activities in accordance with agreed budgets and time scale. To manage department performance against agreed targets and budgets within policies and standards.
4. Setting Goals for QA and QC, monitoring and guiding them to complete the KRA. Leading and monitor performance (in relevant area) according to agreed standards and take necessary action to communicate/ advise/ assist according to performance level.
5. Work across all disciplines (e.g., Manufacturing, Warehouse, Engineering, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies/ internal/ external.
6. To ensure timely response against observation of Corporate Internal audits, Customer audits & Regulatory audits, and ensure implementation of corrective & preventive action on observations.
7. To ensure implementation and execution of Abbott Policies and Procedures at site.
8 **.** To ensure continuous improvement at site with respect to Quality systems and processes.
9. To ensure self-inspection/internal audit and external audit as per schedule/ Plan and regularly appraise the effectiveness/ applicability of the Pharmaceutical Quality System.
10 **.** To ensure timely submission of Regulatory Documents and filing and their compliance.
11. To ensure Cyber Security aspects are implemented at site.
12 **.** To develop, ensure, implement, and maintain a GXP compliant document control system.
13. To ensure that Batch Release is done as per in-house policies and procedures as well as the other other applicable regulations and guidelines.
14. To establish & ensure approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated methods / Pharmacopeia methods / In-house Method for the site.
15 **.** To ensure Product recall is done as site procedure and further coordination with Regional Quality for recall authorization.
16 **.** To ensure that Review Meet is done with the involvement of senior management, to identify the opportunities for continual improvement of products, process, and system.
17 **.** To ensure Quality Risks Management i.e., risks to the quality of the product based on scientific knowledge, experience with the process are mitigated and communicated to senior management as well as linked with the protection of the patient.
18 **.** To approve documentation, as applicable, at site.
19 **.** To approve/reject/extension of Exception/ Deviations and Change Controls activities.
20 **.** To ensure training and effective implementation of current Good Manufacturing Practices.
21 **.** To ensure Good Documentation Practices and Good Laboratory Practices at the site.
22. To ensure that documents are updated and amended as per new pharmacopoeias and regulatory guidelines.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Director Quality Assurance
Posted today
Job Viewed
Job Description
Job Description
Core Job Responsibilities:
1. To make strategy and planning for Quality Assurance and Quality Control for smooth and effective functioning for ODF, LVP & Hormone block.
2.To strategize and plan for continual improvement of GMP aspects in the facility, systems, and procedures.
3.Budgeting for Capital expenses and Operating expenses. Plan and manage departmental activities in accordance with agreed budgets and time scale. To manage department performance against agreed targets and budgets within policies and standards.
4.Setting Goals for QA and QC, monitoring and guiding them tocomplete the KRA. Leading and monitor performance (in relevant area) according to agreed standards and takenecessary action to communicate/ advise/ assist according to performance level.
5.Work across all disciplines (e.g., Manufacturing, Warehouse, Engineering, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies/ internal/ external.
6.To ensuretimelyresponseagainstobservationof CorporateInternalaudits,Customer audits &Regulatory audits, andensure implementationofcorrective & preventive action on observations.
7.Toensureimplementation andexecutionofAbbottPoliciesandProceduresatsite.
8. ToensurecontinuousimprovementatsitewithrespecttoQualitysystems andprocesses.
9.To ensure self-inspection/internal audit and external audit as per schedule/ Plan andregularly appraise the effectiveness/ applicability of the Pharmaceutical Quality System.
10. ToensuretimelysubmissionofRegulatoryDocumentsandfilingand theircompliance.
11.ToensureCyberSecurityaspectsareimplementedatsite.
12. Todevelop,ensure,implement,andmaintainaGXPcompliantdocumentcontrolsystem.
13. To ensure that BatchReleaseis done as per in-housepolicies and procedures as well as the other other applicable regulations and guidelines.
14.To establish & ensure approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated methods / Pharmacopeia methods / In-house Method for the site.
15. To ensure Product recall is done assite procedureand further coordinationwith Regional Quality for recall authorization.
16. To ensure that Review Meet is done with the involvement of senior management, to identify the opportunitiesfor continual improvement of products, process, and system.
17. To ensure Quality Risks Management i.e., risks to the quality of the product based on scientificknowledge,experiencewiththe process are mitigatedand communicatedto senior management as well as linked with the protection of the patient.
18. Toapprovedocumentation,asapplicable,atsite.
19. Toapprove/reject/extensionofException/DeviationsandChangeControlsactivities.
20. Toensuretraining andeffectiveimplementationofcurrentGoodManufacturingPractices.
21. ToensureGoodDocumentationPracticesandGoodLaboratoryPracticesatthesite.
22.To ensure that documents are updated and amended as per new pharmacopoeias and regulatory guidelines.
Quality Assurance/ Quality Control
Posted today
Job Viewed
Job Description
- To conduct inspection of all ongoing activities for electrical installations.
- To conduct inspections for all electrical material deliveries.
- To attend all electrical inspections with client/contractor representatives.
- To submit inspection requests in coordination with concerned site/project engineers.
- Prepare daily QA/QC report regarding inspections, material, Non-conformances etc.
- Prepare weekly surveillance reports, non-conformance reports and verification of corrective actions
- Check the drawings and documents used at site for approvals and compliance with project requirements.
- Ensure that all works are carried out as per the approved method statements and drawings.
- Ensure that all equipment used are calibrated and with valid certificates.
- Assist / coordinate the preparation of the final handing over documents such as QCQA documents, testing and commissioning reports etc.
- Preparation of testing and commissioning method statements in coordination with vendors, General Contractor representative's and project owners representative's
**Skills**:
Proficient in using Microsoft Office Suite (Word, Excel and Outlook), CAD, Ability to read and understand Blueprints Well organized, with a strong emphasis on attention to details and documentations.
**Requirements**:
**Qualification**:
Bachelor of Engineering / Diploma in Electrical / Electronics with minimum 3 years of experience in quality and testing area.
Quality Assurance/ Quality Control
Posted today
Job Viewed
Job Description
- To conduct inspection of all ongoing activities for electrical installations.
- To conduct inspections for all electrical material deliveries.
- To attend all electrical inspections with client/contractor representatives.
- To submit inspection requests in coordination with concerned site/project engineers.
- Prepare daily QA/QC report regarding inspections, material, Non-conformances etc.
- Prepare weekly surveillance reports, non-conformance reports and verification of corrective actions
- Check the drawings and documents used at site for approvals and compliance with project requirements.
- Ensure that all works are carried out as per the approved method statements and drawings.
- Ensure that all equipment used are calibrated and with valid certificates.
- Assist / coordinate the preparation of the final handing over documents such as QCQA documents, testing and commissioning reports etc.
- Preparation of testing and commissioning method statements in coordination with vendors, General Contractor representative's and project owners representative's
**Skills**:
Proficient in using Microsoft Office Suite (Word, Excel and Outlook), CAD, Ability to read and understand Blueprints Well organized, with a strong emphasis on attention to details and documentations.
**Requirements**:
**Qualification**:
Bachelor of Engineering / Diploma in Electrical / Electronics with minimum 3 years of experience in quality and testing area.
Quality Assurance/ Quality Control
Posted today
Job Viewed
Job Description
- To conduct inspection of all ongoing activities for electrical installations.
- To conduct inspections for all electrical material deliveries.
- To attend all electrical inspections with client/contractor representatives.
- To submit inspection requests in coordination with concerned site/project engineers.
- Prepare daily QA/QC report regarding inspections, material, Non-conformances etc.
- Prepare weekly surveillance reports, non-conformance reports and verification of corrective actions
- Check the drawings and documents used at site for approvals and compliance with project requirements.
- Ensure that all works are carried out as per the approved method statements and drawings.
- Ensure that all equipment used are calibrated and with valid certificates.
- Assist / coordinate the preparation of the final handing over documents such as QCQA documents, testing and commissioning reports etc.
- Preparation of testing and commissioning method statements in coordination with vendors, General Contractor representative's and project owners representative's
**Skills**:
Proficient in using Microsoft Office Suite (Word, Excel and Outlook), CAD, Ability to read and understand Blueprints Well organized, with a strong emphasis on attention to details and documentations.
**Requirements**:
**Qualification**:
Bachelor of Engineering / Diploma in Electrical / Electronics with minimum 3 years of experience in quality and testing area.
Quality Assurance/ Quality Control
Posted today
Job Viewed
Job Description
- To conduct inspection of all ongoing activities for electrical installations.
- To conduct inspections for all electrical material deliveries.
- To attend all electrical inspections with client/contractor representatives.
- To submit inspection requests in coordination with concerned site/project engineers.
- Prepare daily QA/QC report regarding inspections, material, Non-conformances etc.
- Prepare weekly surveillance reports, non-conformance reports and verification of corrective actions
- Check the drawings and documents used at site for approvals and compliance with project requirements.
- Ensure that all works are carried out as per the approved method statements and drawings.
- Ensure that all equipment used are calibrated and with valid certificates.
- Assist / coordinate the preparation of the final handing over documents such as QCQA documents, testing and commissioning reports etc.
- Preparation of testing and commissioning method statements in coordination with vendors, General Contractor representative's and project owners representative's
**Skills**:
Proficient in using Microsoft Office Suite (Word, Excel and Outlook), CAD, Ability to read and understand Blueprints Well organized, with a strong emphasis on attention to details and documentations.
**Requirements**:
**Qualification**:
Bachelor of Engineering / Diploma in Electrical / Electronics with minimum 3 years of experience in quality and testing area.
Quality Assurance/ Quality Control
Posted today
Job Viewed
Job Description
- To conduct inspection of all ongoing activities for electrical installations.
- To conduct inspections for all electrical material deliveries.
- To attend all electrical inspections with client/contractor representatives.
- To submit inspection requests in coordination with concerned site/project engineers.
- Prepare daily QA/QC report regarding inspections, material, Non-conformances etc.
- Prepare weekly surveillance reports, non-conformance reports and verification of corrective actions
- Check the drawings and documents used at site for approvals and compliance with project requirements.
- Ensure that all works are carried out as per the approved method statements and drawings.
- Ensure that all equipment used are calibrated and with valid certificates.
- Assist / coordinate the preparation of the final handing over documents such as QCQA documents, testing and commissioning reports etc.
- Preparation of testing and commissioning method statements in coordination with vendors, General Contractor representative's and project owners representative's
**Skills**:
Proficient in using Microsoft Office Suite (Word, Excel and Outlook), CAD, Ability to read and understand Blueprints Well organized, with a strong emphasis on attention to details and documentations.
**Requirements**:
**Qualification**:
Bachelor of Engineering / Diploma in Electrical / Electronics with minimum 3 years of experience in quality and testing area.
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Quality Assurance/ Quality Control
Posted today
Job Viewed
Job Description
- To conduct inspection of all ongoing activities for electrical installations.
- To conduct inspections for all electrical material deliveries.
- To attend all electrical inspections with client/contractor representatives.
- To submit inspection requests in coordination with concerned site/project engineers.
- Prepare daily QA/QC report regarding inspections, material, Non-conformances etc.
- Prepare weekly surveillance reports, non-conformance reports and verification of corrective actions
- Check the drawings and documents used at site for approvals and compliance with project requirements.
- Ensure that all works are carried out as per the approved method statements and drawings.
- Ensure that all equipment used are calibrated and with valid certificates.
- Assist / coordinate the preparation of the final handing over documents such as QCQA documents, testing and commissioning reports etc.
- Preparation of testing and commissioning method statements in coordination with vendors, General Contractor representative's and project owners representative's
**Skills**:
Proficient in using Microsoft Office Suite (Word, Excel and Outlook), CAD, Ability to read and understand Blueprints Well organized, with a strong emphasis on attention to details and documentations.
**Requirements**:
**Qualification**:
Bachelor of Engineering / Diploma in Electrical / Electronics with minimum 3 years of experience in quality and testing area.