1740 Change Control Jobs - Page 17

QC Head 1 Pos based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Mana...

Chief Manager Township Administration (MP 25/13) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement...

Sterile Manufacturing based in Waghodia, Vadodara. The ideal candidate brings 1- 7 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Additio...

The ideal candidate brings 1-6 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Lead microbiology practices including EM, MLT, sterility assur...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

Engineering based in Waghodia, Vadodara The ideal candidate brings 4-7 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Maintain utilities: HV...

Job Summary We are looking for an individual to ensure strict adherence to safety protocols, SOPs, and quality standards, overseeing batch manufacturing activities, and coordinating with various departments to maintain operational efficiency. The role involves planning and executing production activities, coordinating with cross-functional teams, and ensuring compliance with regulatory requirements, critical for maintaining product quality and meeting production targets. Roles & Responsibilities • You will be responsible for adherence to company safety norms, policies, and SOPs (Standard Operating Procedures). • You will oversee batch manufacturing activities according to e-BMR instructions ...

Dear Candidates, We are looking for our USFDA & EUGMP approved plant located at Rasayani, Patalangana MIDC for QMS -Sr. Officer/ Executive. Role & Responsibilities 1.Coordination and evaluation of QMS (Change control, Deviation, CAPA 2.Training Management- Approval of training, allocation of training followed by tracking. 3. New product initiation and evaluation/tracking. 4. Preparation and review of sectional and cross functional department SOPs 5. To carry out all responsibilities assigned by section head as per cGMP, GDP and zero data integrity. Preferred candidate profile: Candidate must have experience in Pharma Formulation Company and exposure in Regulated Market (USFDA & EU - GMP). In...

Role & responsibilities QMS & QMS Trending Audit & Compliance Evaluation, Review/ Preparation of QRM Report Implement Recall/ Return Procedure Training Management Co-ordination of Quality Review Meeting & Management Preparation & revision of SOP Participation in Regulatory Audits Interest Candidate can share their CV on janhavi.shedekar@mjbiopharm.com / 9867700982

Job Description Position Summary We are seeking a Senior Officer- Regulatory affairs (US Markets ) to join our team, he will be reporting to Deputy General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approval Key Responsibilities: Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from targeted markets. Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific). Collate and conduct review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations, E...

Dear Candidates, We are looking for our USFDA & EUGMP approved plant located at Rasayani, Patalangana MIDC for Manager / Section Head IPQA. Role & responsibilities 1. To Lead IPQA activities. 2. Strategies, plan and organize the team's resources to perform day to day operations 3. Ensure Quality compliance as per CGMP requirement in manufacturing facility and inspection readiness at all times and represent in regulatory audits. 4. Review and approval of all SOPs, protocols, reports related to IPQA section. 5. To provide Line clearance by ensuring clearance of documents as per requirement. 6. To verify and coordinate In process and finished product, cleaning validation and any other sampling....

Role Overview: As an Associate Database Administrator at NTT DATA, you will be an entry-level subject matter expert responsible for assisting in various daily database administration tasks. Your role will involve tasks such as database monitoring, backup and recovery, user management, and data maintenance. You will work closely with Change Control, Release Management, Asset and Configuration Management, and Capacity and Availability Management to cater to the needs of users and ensure database security. Key Responsibilities: - Assist with the installation, configuration, and maintenance of database management systems (DBMS) such as SQL Server, Oracle, MySQL, or others as required. - Collabor...

Title: Manager - API Custom Field 2: 2779 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Preparation and review of Standard Operating Procedures. Issuance, review of OOS,OOT,Deviation,CAPA,Change Control & its Management. Handling and monitoring of control samples. To impart internal trainings to DCAL Employees. Review of Calibration records, Instrument Logs of Quality Control. To Review of Analytical Method Validation protocols and reports. Review of the Instrument qualifications and re-qualifications protocols of Quality control. Preparation & review of quality risk assessment docume...

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your role involves facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. Your responsibilities include: - Reviewing documents related to Quality Management System (QMS) & Compliance - Ensuring compliance of Quality Management System - Attending Site Training Program as per site training program and Global Quality Standards requirements - Submitting dossier documents after review against requests received from Corporate regulatory affairs - Responding to queries for submitted dossier against requests receiv...

Responsibilities: Conduct HPLC, GC, UV, water analyses per BMRR. Implement change controls, manage deviations. Perform API manufacturing, intermediate handling, SRP processing.

Date: 30 Sept 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Manufacturing Services Lead and/or participate in regular facility walkthroughs for Biopharmaceutical Operations to adherence to all time audit readiness and compliance with regulatory requirements including Data Integrity assessment. Specimen Signature entry Verified by (Department Training Coordinator) (To be filled manually) Job Description explained by (Reporting Manager/Designee) (To be filled Job Description accepted by (Employee) (To be filled manually) Lead and/or participate in timely reporting of deviations, appropriate investigations to identify root cause or most probable root cause and proposal & implementati...

Ensure Site Quality control, investigation related to OOS, OOT deviations, laboratory incidents, customer complaints and CAPA.Sampling and analysis of Raw materials-APIs, intermediates, solvents and finished products of plant/commercial batches. Required Candidate profile Msc/MPharm), working in API Unit,aware of cGMP, USFDA regulations (21CFR),ICH-guidelines, process and cleaning validation protocols,online manufacturing compliance with regulatory requirements.

Job Title: Internal Audit Analyst Management Level: 11 Analyst Location: Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary : An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You are looking to b...

Position: QA Executive Job Location: Nerul, Navi Mumbai Industry: Ayurvedic / Herbal Pharmaceuticals Qualification: B.Pharm /M. Pharm Designation & Salary: Commensurate with industry experience and expertise. Working Days And Time: 8:00 AM to 5 PM / 6 Days week / Sunday fixed Off. Key Responsibilities: Preparation and implementation of Standard Operating Procedures and Documentation like preparation of MFR, BMR, BPR, all types of Validation, Stability study protocols and reports. To implement and enforce cG.M.P. as per statutory requirements Giving feedback to management regarding discrepancies, deviations and any special matter. To attend external official work, seminars, meetings, discussi...

About the Job Were changing the way people think about customer service, and we need your help! Were looking for a Quality Assurance Team Lead to be responsible for recording, reviewing and evaluating production objectives and performance standards. Working with the Quality Team, this role involves ensuring we are in accordance with both our internal and client-partner metric goals, as well as identifying areas of opportunity, developing solution plans and coaching team members. As Quality Assurance Team Lead, You Will Manage administrative and reporting tasks associated with quality metrics Assist in providing actionable insights to our Operations Team and client-partners Partner with other...

Ruby Chemicals is looking for Specifications Manager to join our dynamic team and embark on a rewarding career journey. Define and maintain technical product specifications ensuring alignment with business and compliance needs. Collaborate with engineering and design teams to translate functional requirements into product specifications. Manage version control, validation, and documentation of specifications across product lines. Support audit readiness, standardization, and product improvement initiatives. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourage job seekers to verify all ...

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

What you will do Amgen is seeking a Sr Associate IS Business Systems Analyst to support and help lead the Change and Release Management processes within the ServiceNow platform. This junior-level process owner role is responsible for the documentation, enhancement, and day-to-day operational support of the change and release lifecycle, ensuring compliance with standard processes while seeking opportunities to streamline and automate. The ideal candidate will assist in managing the change and release process flow, help develop supporting workflows and approvals, track process metrics, and collaborate with stakeholders to drive efficiency and continuous improvement. This position offers an exc...

The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures t...