83 Oos Jobs - Page 4

Creation and Maintain relevant master data in the LIMS, Ensure that the integrity, reliability and performance of the LIMS is maintained. Address and resolve issues arising with the system in a timely manner Required Candidate profile Ready to work in Morning or General Shift To manage the QMS processes—including OOS investigations, Deviations, Incidents & Change Control & to ensure strict adherence to GDP & GMP within lab

Position Title : Executive / Sr. Executive / Assistant Manager QMS Department : Quality Assurance (QA) – QMS Section Location : Formulation- IV, Jarod Experience : 5 to 8 years (in regulated pharmaceutical manufacturing, specifically solid oral dosage forms) Key Responsibilities: Ensure implementation, maintenance, and continuous improvement of the site Quality Management System in compliance with cGMP, ICH guidelines, and regulatory requirements (USFDA, MHRA, EU, etc.). Review and control of GMP documentation including SOPs, Quality Manuals, Validation Master Plans, etc. Handling of deviations, change controls, CAPAs, and risk assessments. Oversight and coordination of internal audits, self-inspections, and participation in regulatory and customer audits. Management of Product Quality Reviews (PQR/APQR) and Quality Metrics. Support in QMS training programs for cross-functional teams. Assist in the evaluation and qualification of vendors through QMS processes. Manage document lifecycle in the electronic documentation management system (EDMS). Drive quality culture and continuous improvement initiatives across the site. Qualifications: B.Pharm / M.Pharm / M.Sc. in a relevant scientific discipline. Strong knowledge of QMS principles and pharmaceutical quality systems in oral solid dosage manufacturing. Experience with regulatory inspections (USFDA, MHRA, WHO, etc.) and audit readiness. Proficiency in handling QMS software systems (TrackWise, Veeva, MasterControl, etc. is a plus). Good understanding of data integrity principles and quality risk management. Key Skills: Excellent documentation and communication skills. Analytical and problem-solving mindset. Ability to work cross-functionally and lead quality initiatives. Attention to detail and a proactive approach.

Planning of work Responsible for overall analysis work in lab by handing team Documentation Reports preparation Review AMV OOS, OOT SOP Preparation.

Provides strategic planning and implementation for the Quality System, including CGMP, GLP regulations, US 21 CFR Part 11 and guidelines to determine the impact to Quality Assurance Systems. Responsible for CAPA,OOT,OOS,Change Control & Deviations.

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating procedures (SOPs), work instructions, and quality records. Prepare detailed reports on quality performance, including non-conformance incidents and corrective actions taken. Process Improvement: Analyze production workflows and recommend improvements to enhance efficiency and quality. Participate in root cause analysis for production issues and implement preventive measures. Key Skills and Competencies: In-depth knowledge of Quality Management Systems and standards. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Proficiency in using quality management tools and techniques. Familiarity with relevant USFD, EU, TGA regulatory requirements and industry best practices.

Responsible for planning and execution of API and intermediates according to pre-approved instructions and raw materials, manpower according to the requirementResponsible for prepare, approve, improvement, continuous review and upgradation of existing production SOPs.Responsible for change controls, deviations / OOS / complaint / OOT, validations, qualifications, calibrations and investigations and evaluations. Trainings and implementing cGMP & Safety, Hygiene in production areas. Responsible for handling of Spray dryer and Homogenizer.Facing the customer audits, regulatory audits and conducting self inspections inter departments New product introduce in the plant and establishment the process for commercial with the help of R & D. Review of technology transfer documents related to production and implement accordinglyResponsible to ensure material handling without spillage and to protect product and deterioration.Involvement in quarterly and Annual product quality review.To Conduct, HAZAOP and Risk assessment of product, system, equipment, item, process as per standard procedure.Ensure Strict adherence to safety, health & environment.Ensure Data integrity

Role & responsibilities To carry out investigations related to OOS, OOT, Incident and Extraneous Peaks to ensure their closure and implementation of CAPA. Responsible for execution of Regulatory Notification as per SOP. To ensure implementation of all proposed actions identified as a CAPA of investigations related to OOS, OOT, and incident. Review of investigation reports, hypothesis protocol and hypothesis reports related to OOS/OOT and Incidents. Co-ordination with R&D, Production, Central Cell, CQA and other responsible for investigations. To prepare and review Quality documents such as (but not limited to) protocols, reports, SOPs STPs Specification, Investigation. Preferred candidate profile Perks and benefits

Preferred candidate profile Looking for a candidate with 2 to 4 years of work experience as QC analyst /AQA reviewer in reputed pharma companies. Should have Knowledge of handling/analytical data review of HPLC, FTIR, UV spectrophotometer, KF Autotitrator, Dissolution apparatus. Have Basic knowledge of CGMP, GDP, Data integrity. Should have Basic knowledge of OOS (Out of specification), OOT (Out of rend), OOC (Out of calibration).