Manager Quality Assurance

Pranay Kumar Jan 11, 2021 689 0

Manager Quality Assurance

URL to Apply- https://www.naukri.com/job-listings-manager-quality-assurance-gss-pharma-private-limited-bengaluru-bangalore-4-to-5-years-010121001616?src=jobsearchDesk&sid=16103713329273901&xp=2&px=1

GSS Pharma Private Limited 3.9(7 Reviews)

4 - 5 years

Not Disclosed

Bengaluru( Whitefield )

Job description

To instruct and guide all QA / CQA personnel for implementation of approved procedures/protocols/master document and to maintain high degree of work discipline.
Accountable for effective implementation of Pharmaceutical Quality Management Systems in accordance with the company's Quality policies and procedures including Change Management, Deviation management, Product Complaints, Recalls, Product Quality Review, CAPA Management and Quality Risk Management.
To coordinate with all the departments for implementation of Regulatory Intelligence and Data integrity related activities.
To review and approval of Site Master File, Quality Manual, Validation Master Plan.
To work for constant up-gradation in the existing Pharmaceutical Quality Management Systems through continuous improvement plan.
To coordinate with customers, contract givers while preparation, review and approval of Technical Agreements.
To ensure the adequate investigations, root cause identification, CAPA proposal and implementation/effectiveness of proposed CAPA are done for product complaints.
To support and ensure the compliance of activities related to vendor policy.
Responsible for coordinating and responding queries received from customers, regulatory agencies etc.
To ensure that non - conforming product or materials are handled as per the respective procedures and to make decision related to further disposition of the material or product batch.
To appraise the Senior Management related to; Inspections product complaints, Continuous Improvement Plans, Regulatory Guidance updation, concerns in vendor policy implementation, Data Integrity, Non-Conforming Materials / Products any developmental activities that needs senior management approvals.
To Authorize and Approve the change controls, Deviations, incidents, Art Work revisions, Packaging Specification, Product Information Format (PIF) and Art work in QAMS in absence of Head Technical Services or on need basis.
To ensure that appropriately performing the investigations, Root Cause Analysis, Risk Assessments, Identification of CAPS's, Implementation/effectiveness monitoring and reviewed periodically where applicable.
To review and provide approval in documents wherever applicable.
Any other responsibilities as and when assigned by Management.
Review of Artworks, Proofs, Shade Cards and Maintaining the Records