Section Head - QA

Division

Department

Employment Type

Job Purpose

Drive compliance of unit as per Quality management system and regulatory expectation while seeking continuous improvement in cGMP to ensure

Accountabilities

I. Establish system for appropriate investigations of various non-conformances of quality management systems, to determine root cause and implementation of CAPA, as per cGMP requirements
II. Design plan for compilation, review and on-time closure of QMS documents in order to meet compliance with respective quality systems
III. Control the system to analyse QMS documents for completeness and accuracy in line with cGMP requirements
IV. Seek opportunities of continual improvements in QMS by review of regulatory updates through simplification of SOPs / procedures to ensure adherence to cGMP requirements
V. Plan regulatory compliance of audit observations by monitoring and supervising of compliance till its closure to meet regulatory compliance
VI. Direct and supervise communication to provide feedback to internal and external customers on queries related to QMS documents/ deficiency as per standard procedures and technical agreements
VII. Develoaid them in performing their job roles better and contributing to achieving team goals

Education Qualification

B. Pharm. / M. Pharm. / M. Sc

Relevant Work Experience

8-12 years for B. Pharm or 6-8 years for M. Pharma / M. Sc.

Competencies/Skills

Job Location

Rangpo

Shift Hours