Assistant Corporate Quality Assurance Manager

  Discussion with purchase team & plant team for vendor audit plans pertaining to new site/new material/alternate vendor development. 

  Preparation of vendor audit schedule and to coordinate with various departments for the audits as per schedule. 

  To co-ordinate with manufacturers and perform audit of Raw Materials and Packaging Materials vendors. 

  To prepare the vendor audit report and ensure end to end closer of compliance. 

  To be a part of Internal Audit and External Audit team (as and when required) conducting the audit for all sites of Eris. 

  To communicate and follow-up with purchase for appropriate CAPA related to RM/PM vendor facilities. 

  To participate and investigate out of specification results reported by quality control of Eris in raw materials and co-ordinate with manufacturer. 

  To be a part of market complaint investigation, product recall and returned goods as and when required.

  Responsible for review of SOPs related to vendor qualification and to ensure system harmonization at all sites of Eris.

  To impart training to Eris personnel as and when required. 

  Any other responsibility assigned by Management from time to time. 

 Key Skill: 

  Candidate should have exposure of work as Quality Assurance in Sterile API manufacturing unit. 

  Candidates should have worked in vendor qualification activities and conducted GMP audits of Formulation and RM/PM manufacturers and should have knowledge of overall GMP aspect of manufacturing. 

  Candidate should have expertise in investigation, trouble shooting and execution of gap analysis of QA/ QC system and effective implementation of cGMP/GLP and regulatory requirements.