BSc. / MSc. / BPharm. / MPharm. Responsible for material planning, inventory monitoring, production planning coordination, and supply chain execution to ensure timely availability of materials and smooth manufacturing operations.
Ensure compliance with cGMP, GLP and regulatory requirements for in-process and finished products. Review and approve batch records, deviations, investigations and CAPA.
Established in 2016, ANNORA Pharma is committed to provide medicines with highest quality, safety and efficacy that meets the needs of the customers with applicable statutory and regulatory requirements.
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. Today, Intas is present in more than 85 countries worldwide and is growing at 20% CAGR. Around 70% of its revenues come from the international markets, particularly the highly regulated markets of EU and US. At Intas, every day and everyone works to create a world of good health, happiness and hope.
Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Lead cross-functional regulatory discussions, align stakeholders on submission strategy, and communicate regulatory implications to support business and product development decisions.
Experience in breakdown and preventive maintenance of vial washing, filling, capping, autoclave and labelling machines, jacketed vessels and lyophilization.