QA Manager and MR

Gurgaon, India | July 8, 2020

This QA leader will act as management representative, Implement the QMS (Quality Management System), ensure that the company will comply with applicable regulatory requirements and will supply high quality products at the quality level which was agreed with its customers.
Responsible for plant quality compliance initiatives and programs. Site liaison for corporate quality programs.
Proactively lead site quality system enhancement projects to ensure no action resulting from a regulatory inspection.
Execute and/or coordinate Risk and Gap Assessment analysis to ensure full compliance to CFR requirements.
Work in partnership with all departments to provide expertise and promote understanding of compliance requirements.
Prepare and Lead USFDA inspections on site .
Key contact for Regulatory Authorities and notified body
Build and Manage a highly professional QA/QC team

Key responsabilities: 

QA & QC systems and testing labs
QA/RA Management Representative
Defining & Implementing QA systems (SOPs ,Batch release, CAPAs, change control ,complaint Management, MRBs, internal inspection, supplier Quality, MDR, Validations review and approval,etc.)
Leading External and Internal Inspections
Responsible for QA & QC systems continues improvement and implementing Company’s Quality Culture in cooperation with the relevant functions.
Execute gap analysis and/or Risk Assessment to ensure evaluation of key areas, such as manufacturing operations, laboratory, maintenance and engineering are in compliance with all USFDA regulatory requirements for Medical Devices.
Develop and maintain a process for plant FDA readiness.
Provide training pertaining to USFDA inspections, e.g. FDA hot topics, interaction with USFDA officials, new regulatory approaches in inspections etc.

Minimum qualification required:

MSc. Degree in Science or technical fields, Bio Medical Engineer a plus.
12 to 15 years of experience in a Medical Device or Pharmaceutical Global company.
Minimum 5 years’ experience in team Management.
Proven working knowledge with USFDA including successful USFDA inspections in leadership roles-must
Good knowledge of the relevant regulations and standards (ISO13485, 21 CFR PART 820 and PART 803)