Quality Assurance Officer / Sr.Officer

KWALITY PHARMACEUTICALS LTD.

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 companyhas registered its products in different countries of Europe, Africa, Asia, Central American, and South American Countries & CIS Countries. What we are looking for :

Qualification and Process Validation ( Injectables )

Role & Responsibilities :

Sampling of In-process samples as per BMR, BPR and validation protocol. To prepare, review and execute the validation protocol and report. To prepare, review and execute the qualification protocol and report. Maintaining Hygiene and cGMP monitoring in respective production area. Maintaining all documentation as per GDP at the respective workplace.

Responsible for Review of BMR and BPR.
Responsible for issuance, controlling and retrieval of documents. Responsible to prepare and review of APQR. Responsible for execution and report compilation of Equipments and HVAC qualification. Responsible for initiation of change control, deviation and other QMS tools. Responsible for preparation & review of SOPs. Responsible for temperature mapping in controlled areas. Responsible for preparation and review of SMF, VMP and Quality Manual. Media Fill protocol and report preparation and review. Process validation protocol and report preparation and review. Cleaning validation protocol and report preparation and review.