17 Sop Review Jobs

As a Quality Assurance Inspector, your primary responsibility will be to perform various inspections based on studies, facilities, and processes. You will also be required to participate in regulatory inspections conducted by organizations such as NGCMA, CDSCO, NABL, and USFDA. Your role will involve reviewing Standard Operating Procedures (SOP) and quality tools such as deviation, Corrective and Preventive Actions (CAPA), incidents, and change control. Additionally, you will be responsible for reviewing documents related to computerized system validation and instrument qualification.,

Validation Master Plan (VMP): Lead the preparation, review, and maintenance of the Validation Master Plan (VMP) to ensure alignment with industry standards and regulatory requirements. Qualification/Validation Protocols: Review and approve Qualification/Validation protocols to ensure they comply with CGMP standards and regulatory requirements. Quality Systems Maintenance: Ensure all quality systems are maintained according to CGMP requirements and monitor compliance across all departments. SOP Review & Approval: Review and approve Quality Assurance (QA) SOPs as well as SOPs from cross-functional departments to ensure consistency and regulatory compliance. Document Review & Compliance: Review...

Validation Master Plan (VMP): Lead the preparation, review, and maintenance of the Validation Master Plan (VMP) to ensure alignment with industry standards and regulatory requirements. Qualification/Validation Protocols: Review and approve Qualification/Validation protocols to ensure they comply with CGMP standards and regulatory requirements. Quality Systems Maintenance: Ensure all quality systems are maintained according to CGMP requirements and monitor compliance across all departments. SOP Review & Approval: Review and approve Quality Assurance (QA) SOPs as well as SOPs from cross-functional departments to ensure consistency and regulatory compliance. Document Review & Compliance: Review...

Role & responsibilities 1.Stability Studies Management: Planning and management stability studies, Comparative Stability and Forced Degradation (FDS) Studies, Reference product age related studies of all the projects. Compilation of stability data, interpretation, and data trending. To review the data, related DRS and LNBs etc. 2. Drafting / review / approval of operational SOP, LP, SLP and Stability Protocols, Summary Sheets, Reports as required. 3. Planning and management of the IRS: Planning and management for establishment of internal reference standards. Management of IRS stability studies, issuance, compilation and trending the retrospective data of the established internal standards. ...

Company Description: LCI Group, based in Sydney, Australia, is a leading student recruitment agency with established relationships. Trusted by over 1,300 top universities and colleges worldwide, we have helped more than 30,000 students achieve their educational goals each year. With 26 offices across 16 countriesincluding China, Southeast Asia, Oceania, EMEA, and the Indian Subcontinentwe are expanding into the CIS region. LCI Group provides customized, integrated solutions based on a deep understanding of the education sector and a proven track record of success. Role Description: This is a full-time on-site role for a GTE Counsellor at LCI Group in Gurugram. The GTE Counsellor will provide...

As a Manager Quality Assurance at Syngene International Ltd., you will be responsible for ensuring compliance with all national and international regulatory agency requirements related to API manufacturing. Your role will involve evaluating and approving vendors/subcontractors, reviewing and approving various reports such as SOP, analytical method validation, and calibration reports, and coordinating review meetings to maintain the effectiveness of the quality system. You will be expected to have a strong understanding of regulatory requirements from agencies such as ICH, USFDA, WHO Geneva, PMDA Japan, and others. Additionally, you will play a key role in the approval of protocols and report...

The primary objective of the role is to lead the ongoing development and enhancement of Sodexo's Safety Culture and Safe Behaviors by demonstrating safety leadership qualities and integrating the Group Zero Harm Mindset initiatives. It involves implementing the APMEA Food and Health and Safety Processes across various sites, adapting them into local processes to ensure legal compliance within the designated country or area of responsibility. The ultimate goal is to provide safe and compliant work solutions for operational teams offering services, achieved through the operational application of APMEA HSE systems and procedures, identifying policy and procedure gaps, and supporting the develop...

As the Production Head, you will be responsible for overseeing the manufacturing activities in the pharma API industry. With 15 to 19 years of experience, you will be based at the Sandhurst Road Mumbai head office with a salary of 15 lpa. Your key responsibilities will include reviewing, approving, and distributing work instructions for manufacturing activities. You will ensure the production activities align with the production plan and make decisions regarding new batch production. Monitoring batch processes and reviewing online documentation such as BMR, BPRs, logbooks, and daily records will also be part of your role. Furthermore, you will be in charge of qualifying production equipment,...

As a General Manager (Engineering) in our organization, you will be responsible for overseeing a wide range of engineering activities and operations. With a Bachelor's degree in Electrical & Electronics and 22 to 24 years of experience, specifically in regulated markets and a sterile background, you will play a key role in ensuring the efficiency and effectiveness of our engineering department. Your primary responsibilities will include reviewing and approving various engineering GMP documents, preventive maintenance reports, and qualification documents. You will also be involved in the review and closure of Quality Management System (QMS) documents, as well as other related documentation. A...

Role & responsibilities 1. Preparation of SOP's for corporate activities 2. Review of SOP's of Corporate department 3. Review of GMP documents 4. Implementation of SOP's and system in Corporate 5. Any other tasks assigned by HOD 6. Documentation knowledge and control Preferred candidate profile Computer skills - Word, Excel, Communication, Co-ordination.

Discussing with process owner and drafting SOP Reviewing the process and identify inefficiencies in operational processes. Identify and evaluate operational, financial, and regulatory risks and Identify control deficiencies and suggest improvements. Timely Updating SOP with controlling version records. Verify records and process related to client transactions, compliance, and operations. Support in review of SEBI regulations, exchange rules, and internal policies. Monitor and report compliance violations. Candidates working for stock broking companies will be preferred. Exposure of Internal Audit and SOP review is must. Show more Show less

As a Senior Study Abroad Counselor at V&U Intellect Consultants, you will play a crucial role in guiding students through their international education journey, with a focus on study abroad opportunities in Australia and the USA. With your expertise and empathy, you will lead one-on-one counseling sessions, assist in university selection, application processing, SOP review, and visa guidance. Your knowledge of admission requirements, deadlines, and visa policies for both countries will be essential in providing accurate information to students. Handling walk-ins and scheduled appointments with professionalism, maintaining student records meticulously, and ensuring diligent follow-up througho...

You should have a minimum of 3-8 years of experience in warehouse inventory management, particularly in 3PL and cold chain industries. Your responsibilities will include coordinating with multiple locations to gather and analyze MIS and monthly stock audit reports. It is crucial to excel in inventory reconciliation to identify and resolve errors resulting from incorrect entries or miscounts. Proficiency in advanced Excel and Microsoft Navision is essential for data analysis and providing solutions to branch teams. As a Warehouse Executive/Manager, you will be required to conduct stock audits at various locations and review Standard Operating Procedures (SOPs) at the warehouse level. Addition...

You will be responsible for performing chemical and instrumentation analysis on various materials including in-process, raw materials, packing materials, intermediates, and finished products. Your primary goal will be to ensure compliance with dispatch timelines as per the monthly schedule provided by PPL. Your duties will include conducting instrumentation analysis using ICP-MS and LC-MS for the mentioned materials to meet dispatch timelines. Additionally, you will be involved in analytical method developments, validations, transfers, and verifications using ICP-MS and LC-MS/MS. You will be required to prepare and review protocols, worksheets, and reports for method developments, validation...

Job Title: GLP-Quality Assurance Personnel Location: Bangalore, KA, IN, 560099 Syngene International Limited, Bengaluru is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is a top priority, with a focus on ensuring safety guidelines, procedures, and SOPs are followed diligently. As a GLP-Quality Assurance Personnel at Syngene, you will play a crucial role in aligning laboratory practices with Good Laboratory Practice (GLP) guidelines to maintain the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory envir...

Role & responsibilities Job Responsibilities knowledge on Quality control function like FP/RM/PM/Stability of Solid dosage forms. good knowledge on QC Instrumentations trouble shooting of QC instruments like Auto titrator, HPLC, GC etc. 21CFR part 11 compliance and Computer system validation Investigation like OOS, OOT, events and deviation management. LEAN management and Good presentation skill exposure to Regulatory Audit handling and management review of SOPs versus practices for gap analysis. Trending of QC data and deriving action plan for compliance readiness Preferred candidate profile B.Pharma / M.Sc with 4 to 6 yrs experience as QC investigator. good in english verbal and written co...

Role Description Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Collaborate with raw material suppliers to ensure alignment...