Position : Sr.Manager (QMS)

Experience : 15 to 18 years in QA/QMS (Min 5 years as QMS lead)

Qualification - MSc /MPharma

Job Responsibilities:

• Responsible for QMS Team lead for Block

• Hands on for Quality Management System,

• Annual Product Review / Continued process verification

• Investigation

• Risk Assessment

• Product Quality Complaints, Filed Alert Report (FAR), Quality Alert and Recall

• Corrective Action & Preventive Action (CAPA) and Effectiveness check records.

• Change Control, Deviation Reports, Extension Reports

• SOPs

• Document cell management

• Site Master File

• Review and approval of Quality Metrics and Quality Review Board presentation.

• Identify and implement solution for improving existing site quality assurance systems and processes.

• Involvement in co-ordination of activities for software like Track Wise, EDMS, BRMS, APR software etc. at plant.

• Responsible for ensuring all time audit readiness, Data integrity norms.

• Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.

• Exposure with regulatory inspection like USFDA/MHRA/Health Canada and should have good communication and presentation skill

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.