Job Detail

Site Head – Quality Assurance – API

Quality Planning and scheduling

Admin
Banglore
Full Time
Category : Manufacturing Salary : Experience(s) : 14 Year

Overview

Salary Best In the Industry Quality Planning and scheduling. Involving in all quality related matters in the site. Budgeting for Quality Assurance Department. Implementation of company's Quality policy and GMP Regulations at site. Overall monitoring of quality activities in the area of operation. Coordinating with team members for achieving quality requirements. Review of internal GMP rounds report / inspection outcome and review of action plan. Handling of Customer / Regulatory Audits. Review of audit reports and CAPA response reports. Handling of Vendor audits. Response to regulatory queries and deficiencies. Review of Internal Audit Reports. Review and resolution of customer complaints. Handling of Product Recalls Review and Approval of Out of Specification. Review and Approval of Out of Trends. Investigation of deviation, batch failure, Rejection and final disposition. Responsibility of batch release. Review and approval of TTDs. Review and Approval of Quality Agreements. Approval of validation /qualification protocols and reports. Approval of Quality Documents which includes SOPs, EOPs, IOPs etc. Approval of Annual product Reports. Training of company personnel in Quality Management Systems. Recruitment of personnel to the QA Department. Responsible to follow the safety and environmental procedures deployed in the site. Coordinate with central documentation team and corporate team for harmonization of SOPs and review of the procedures finalized at Central documentation

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Salary:INR Best In the Industry

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production , Manufacturing , Maintenance

Role Category:Senior Management

Role:Head/VP/GM-Quality Assurance/Quality Control

Keyskills

Quality Management     QMS    IPQA     Audit & Compliance

Desired Candidate Profile

Education-

UG:B.Sc – Chemistry

PG:M.Sc – Chemistry

Doctorate:Any Doctorate – Any Specialization, Doctorate Not Required

MSc. (Analytical / Organic Chemistry) with 15 to 18 years of experience in QA of API manufacturing

Must have faced international audits like WHO Geneva, EDQM, MHRA, USFDA etc. in a leading role

Should have an experience of closely working with Regulatory Affairs

Should have strong Analytical Skills

Knowledge of QA, QC analysis and interpretation of results, cGMP and GLP

Analysis and Trouble shooting in analysis

Managing Audits

Hard working, Positive Attitude, Excellent Communication Skills, Willingness to Learn

Hands-on Approach, Energetic, Hardworking, Meticulous and Analytical

Good Leadership qualities and Interpersonal Skills

 

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