Plan, Co-ordinate and follow-up for effective implementation of QA related policies and system in the organization.
Responsible to handle the Quality products and Quality norms at site.
Preparation of validation master plan and their periodical execution.
Approval of plant SOPs, STPs , various protocols/ reports and their implementations.
Handling of shop floor quality system related activities.
Responsible for batch release after completion of related documents and ensuring the quality product.
Organizing the trainings as Training coordinator on various SOPs/Guidelines.
Handling of market complaints
Responsible for internal & External Quality audits / Vender audits at their manuf. site.
Undertakes quality and technical gap analysis for new product manuf. requirements at site
Direct involvements in the production planning, product deliveries on time and promptly act if any type of delay with respect to any technical issue.
Support to other manufacturing site with respect to the Quality documents, SOP/STP/SPEC and various type of Protocols.
Ensuring Technology Transfer from R & D at the manufacture site with manuf. Process, Analytical method transfer, Packing trials and their documentations.
Provide Training to the team members on GMP/ Quality norms.
Co-ordination with regulatory department for filing the dossier in different countries.
Co-ordination with State/Central drug authorities for license of new pharmaceutical product, renewal of old license, issuance of COPP for export, Non-Conviction Certificate Marketing certificates, Performance certificate, Free sale certificate, Test Certificate etc.
Candidate should have following abilities:
Teamwork & motivation
Liaison & networking
Planning & Organising
Diplomatic, resourceful and a lateral thinker
Commitment to equality and diversity, and the ability to translate that commitment into
Actions that lead to positive outcome.