Job Details

Implement and improve the system management for ISO 9001 , ISO 15378 and 21CFR part 11.
Lead the risk analysis team and ensure follow up.
Ensure CGMP rules adapted to our business are implemented, respected.
Manage documents into GMS.
Responsible for GMP and IPC training.
Ensure all quality related operations in accordance with written procedures.
Preparation of validation packages, SOP , Protocol etc.
Knowledge of IQ, OQ, PQ systems.
To co-ordinate with external team, for engineering system validaiton, like AHU, Cleanroom facility etc.
Coordinating and facilitating customer for regulatory audit.
Ensure customers requirements are well defined. Validate Customer Quality Agreements and questionnaires.
Lead customer complaints (CAPA), CAPA team.
Is independent from production (functional link with the head of Quality). Is allowed to stop production. Is the site management representative.
Escalate a risk of recall to upper management and the criteria for recall.
Lead customer audits, and is responsible for audits follow up (CAPA).
Ensure that root cause analysis methodology is well applied.
Manage and document handling of returns and restricted materials.
Making sure that critical deviations are investigated and resolved.
Preparation of validation protocols and reports.
Preparation and revieweing all GMP related documents of site, FG release, with the help of respective dept etc.
Changes relateted GMP activities ( Facilities, equipments, facility/layout, speficication ).
In absence of Quality Manager, will be responsible for the site, as Quality Head.
Approving all changes in batch manufacturing records, packing records, SOP etc.
Lead and coach all the employee of the plant.
Is responsible for people development (evaluation, training, talent identification.
Coordinating with regulatory affairs for DMF filing and for defeciency response.
Coordinating with site operation team, for the preparation of ,all regulatory and customer audit.
 

Chemical, Mechanical or Plastic Engineering Degree.
Minimum 8years experience in related field.
Experience in the following would be an advantage : Lean Sigma methodology, 8D methodology, ISO 15378.
Knowledge of Regulatory Audits, USFDA.
Fluent in spoken and written English.
Knowledge of Tamil is a must.