Job
Description
KWALITY PHARMACEUTICALS LTD. 6TH, MILE STONE, VILL. NAG KALAN, MAJITHA ROAD, AMRITSAR- 143601.(INDIA) About Our Organisation : Kwality Pharmaceuticals Ltd. is a manufacturer of finished pharmaceutical formulations in a dosage form. The company was incorporated on May 4 1983, and is ever progressing in Domestic and International markets. Kwality Pharma was Incorporated on May 4th 1983 by Mr. Ramesh Arora ( Founder ) of the company . Our company is based on its commitment to high quality and timely supplies. Kwality Pharmaceuticals Ltd are leading manufacturer & exporters of pharmaceutical formulations in Liquid Orals, Powder for Oral Suspension, Tablets, Capsules, Sterile Powder for Injections, small volume injectables, Ointments, External Preparations, ORS and many more.... in various categories like Beta Lactam & non-Beta Lactam, Hormones, Cytotoxic (Oncology) and Effervescent as per new GMP norms. The company specializes in handling customized business as per the requirements. The company has registered its products in different countries of Europe, Africa, Asia, Central American, and South American Countries & CIS Countries. What we are looking for : QMS / Process validation / Method Validation Role & Responsibilities : • To review, maintain and implement change control management. • Tracking and trending of CAPA for site and its verification of CAPA effectiveness. • Handling of regulatory inspections and preparation of audit compliance reports. • To review and approval of sampling protocols, validation protocols and reports. • Responsible for review and tracking of technical agreements for the site. • To involve in Preparation, Approval, Issuance and Retrieval of Documents. • Responsible for assessment, review and tracking of vendor service agreements. • To ensure preparation and approval of Annual Product Quality Reviews. • Review of incident investigation reports and monitoring of CAPA arising from the incidents. • To Review and preparation of specification / STP • To ensure adequate and timely review, approval of incident investigations and verification of the action plans. • Review and approval of Site master file, Quality Manual and Validation Master Plan. • To ensure reserve samples of finished products are maintained as per defined SOP. • Ensure cGMP compliance at site. • Responsible for ensuring quality and compliance wherever the GMP activities performed within the department and at the site.
