8 - 12 years

10 - 14 Lacs

Bavla

Work from Office

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

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Head Quality Assurance Energon Labs

18 - 22 years

20 - 30 Lacs

Hyderabad

Work from Office

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.

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OSD Production QMS / Senior Officer Intas

3 - 7 years

3 - 8 Lacs

Ahmedabad

Work from Office

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.

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Manager/Deputy Manager Cdymax India Pharma

8 - 13 years

10 - 15 Lacs

Bengaluru

Work from Office

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

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Senior Officer Investigations. Glenmark Pharmaceuticals

5 - 6 years

5 - 6 Lacs

Baddi

Work from Office

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

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AQA Reviewer- Officer Emcure

2 - 4 years

3 - 6 Lacs

Pune

Work from Office

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).

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