244 Oot Jobs - Page 5

Conduct quality inspections and tests on raw materials, in-process production, and finished products.Monitor and document quality control processes and compliance with quality standards.Identify defects or deviations

Conduct regular inspections and audits of products, processes, and systems.Identify quality issues and implement corrective actions.Develop and maintain quality documentation, including SOPs and checklists.

Conduct regular inspections and audits of products, processes, and systems.Identify quality issues and implement corrective actions.Develop and maintain quality documentation, including SOPs and checklists.

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications

TECHNICAL AND JOB SPECIFIC: Review of Technical Design Documents and Unit Test documents. Preparation and review of calibration, Preventive Maintenance, Breakdown SOPs . Handling of deviations, change control, CAPA, OOS/OOT investigations. Knowledge of qualification and calibration of instruments/equipments. Knowledge on creation of Equipment Functional Location, Bill of Materials, Work Centers, classes and characteristic, measurement points, Task List, Maintenance Plans, Warranties, Knowledge on work order management, Preventive Maintenance, Calibration Management, Breakdown Maintenance, Revalidation, Mapping, Refurbishment process, Inventory Management, Master Data Management( Creation and...

TECHNICAL AND JOB SPECIFIC: Review of Technical Design Documents and Unit Test documents. Preparation and review of calibration, Preventive Maintenance, Breakdown SOPs . Handling of deviations, change control, CAPA, OOS/OOT investigations. Knowledge of qualification and calibration of instruments/equipments. Knowledge on creation of Equipment Functional Location, Bill of Materials, Work Centers, classes and characteristic, measurement points, Task List, Maintenance Plans, Warranties, Knowledge on work order management, Preventive Maintenance, Calibration Management, Breakdown Maintenance, Revalidation, Mapping, Refurbishment process, Inventory Management, Master Data Management( Creation and...

Summary Job Functions: Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols & Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor Compliance in BBM Facility. Responsible for transactions required in software related to GMP activities Key Responsibilities: - Responsible for In-Process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/ WCB/ EPCB Vial/ CI/ DS for batch processing, Verification of process steps as applicable and review of various processing parameters and its associated documentation related to BBM facility. - Review of new & revised documents and related transactions in respective software. (SOP, E...

QMS Documentation: Handling change control, deviation, CAPA (Corrective & Preventive Actions), complaints, OOS (Out of Specification), OOT (Out of Trend), etc. Audits & Compliance: Risk Assessment: Product Quality Review (PQR)

QA Manager OSD/Liquid formulation background.Must have experience in BMR, batch release,validations,qualifications,SOPs,GMP,audits,QMS(Deviation,OOS, OOT, CAPA), tech transfer. Analytical exposure is an added advantage Resume to hrd@stedmanpharma.com

As a professional in the field of Quality Assurance, you will be responsible for various key tasks to ensure compliance with regulatory standards and the maintenance of high-quality systems. Your expertise in FDA GMP audits will be essential in guaranteeing adherence to regulatory requirements. Additionally, your experience in establishing and overseeing Quality Management Systems (QMS) will play a crucial role in maintaining compliance with GLP and cGMP standards. Your proficiency in creating, reviewing, and maintaining Standard Operating Procedures (SOPs) will be vital in ensuring consistency and efficiency in processes. You will also be tasked with managing and implementing change control...

Responsible for Shredding and maintenance, all Layouts along with Eng Team, doc along with EHS, HR and Eng. Team, water system validation documents, conducting Transport validation, Review and finalize the protocol Manufacturing Licencing activities

We are hiring for Quality Control for Executive / Senior Executive role Applications are invited for the position of Executive QC and Sr. Executive QC Interested candidates can apply for this position. Required experience: 2 to 10 years Candidates with experience in handling of sophisticated instruments e.g. HPLC, GC, UV, IR, Dissolution apparatuses and other laboratory equipment are preferred. Analysis of RM, In-process, FP Samples. Experience in calibration of all the instruments. Experience in analysis of Process Validation and Cleaning Validation Samples. Well versed with Good Laboratory Practices ,Data integrity concepts, investigations, OOS, OOT and Laboratory Deviations. Exposure of R...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5-8 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/...

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...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat The ideal candidate brings 5 to 8 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/...

Quality Assurance (QA) based in Latur The ideal candidate brings 0-1years 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) Strengthen QMS: author/re...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 8 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/Le...

Assistant Manager QA 1 Pos based in Amritsar. The ideal candidate brings 8-10 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). Strengthen...

HVAC & Water System Engineers 2 Posts based in Amritsar. The ideal candidate brings 2 - 4 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)...

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...

Micro Head 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). Lead mi...

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 improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

The ideal candidate brings 8 to 10 year 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) Additional info: Key Skills: QMS (Change Control, Deviation...

Designation - Sr. Executive / Asst. Manager - Quality Assurance Company - Leading Pharma Raw Material Mfg. Company Job Location - Ahmedabad Qualification - B.Sc. / M.Sc. / B.E.- Chemical / B.Pharm Experience - Min. 6+yrs. and above Required Candidate profile Company coming up with Greenfield Project Responsible for handling QA / GMP Related documentation QMS, Audit Preparation, Vendor Questionnaire, Market Compliant & Customer Compliance

Title: Executive API Custom Field 2: 2806 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 Operation Procedures, Review of executed BMR, BPR, ECR, etc, Responsible for Change control management, Preparation and Review of Annual product review, Responsible QA Release, Responsible for Process Performance Qualification and Cleaning Validation, Handling of Deviation, Responsible for OOS, OOT investigation related to manufacturing, Responsible for reviewing of Line Clearance activities, Responsible for Finished product sampling Job Segment: QA, Quality Assur...