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Head Corporate Quality Assurance

Mumbai, Maharashtra

Fact Personnel Pvt Ltd

Job Description

The role of CQA head is to define the quality systems based on current regulatory guidelines, train the location QA on the quality systems and monitor effectiveness of the QMS through routine audits in order to have consistent compliance to systems and product specifications.

Job Responsibilities:

1. Defining and implementing the QMS:
Preparation and routine review of the Quality Policy + Quality Mannual to ensure that it is in line with current regulatory requirements and that it provides the framework for working SOPs & Systems,
Training of the plant QA on the changes in the QMS related policy documentation,

2. Effectiveness of QMS:
Monitor for effectiveness of CAPA emanating from audits, complaints and internal review,
Ensure preparedness for external audits (customer and regulatory), participate in critical audits and communicate findings of one location CAPA at other locations as well,
Audit responses and closure,

3. Vendor Qualification (Materials, Services, Logistics):

4. New + Existing Plant, process and equipment qualification:
Liaise with Projects & Service Provider for new facility qualification in line with VMP
Define the VMP,
Train Projects, Operations, Plant QA on validation & qualification requirements,
Monitor implementation of VMP,

5. Risk assessment and mitigation:
Define the risk assessment policy in line with ICH guidelines,
Identify candidate, system, process, etc for risk assessment,
Train the team for risk assessment,
Support plant in risk assessment,
Monitor for risk mitigation compliance,

Key Competencies Required:

1. Sound knowledge of Quality Management Systems
2. Sound knowledge of statutory and regulatory requirements,
3. Pharma concepts,
4. Process knowledge to facilitate qualifications as well as risk assessments,

1. Team working and ability to work with own team as well as cross-functional teams,
2. Planning & prioritizing,
3. Good communication with internal and external customers,
4. Able to understand the regulatory requirements and translate into logical system for capsule business,

Company Description

Fact Personnel Pvt. Ltd. shall perspire to continuously research and innovate new methods... of recruitment to facilitate easier and faster recruitment and of quality personnel.
Fact Personnel Pvt. Ltd. shall always perspire to extend its horizon to entire world, and provide world class service to its clients and its candidate as well. It shall perspire to become a knowledge house for its candidate and other people involved so as to contribute to development of every single person. We consider it as our duty as not only to locate the best talent available but also to contribute to the development of individual talents as well in whatever small way we can.
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Additional Information

Last updated:
Job type:
Full time
Position type:
Minimum experience:
More than ten years
Compulsory Education
Jobs in Quality / Testing / Process Control
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