1019 Cgmp Jobs - Page 8

Job Description Summary Primary focus of this position is to support optimizing, implementing, and validating components/elements of a medical device The candidate will assist in conducting design and process qualification and validation; assist/write technical documents, validation protocols and reports; perform/coordinate hands-on testing of a device; assist in failure investigations; and support other activities from R&D, Quality, Operations, and Regulatory Affairs, Job Description Essential / Key Job Responsibilities (including supervisory and/or fiscal): Design: serve as subject matter expert of components of a medical device, including design evaluation for proposed changes to material...

Roles and Responsibilities Conduct stability analysis of APIs, excipients, and finished products according to cGMP guidelines. Perform method validation, cleaning validation, and equipment qualification activities as per SOPs. Ensure compliance with regulatory requirements by maintaining accurate records and documentation. Collaborate with cross-functional teams to resolve deviations and implement corrective actions. Participate in audits conducted by USFDA, WHO, EDQM, and other regulatory bodies.

Role & responsibilities Performance of Calibration activities Trouble shooting of Instruments Performance of Temperature Mapping Schedule Preparation & Execution Preferred candidate profile The incumbent should have 5-6 years of relevant experience

Role & responsibilities Responsible for all in process Quality Assurance Activities Document issuance and control Preparation and review of SOPs, Protocols, Reports, BMR, BPR and QC Specifications Issuance and review of BMR and BPR and other quality system documents Internal audit and its compliance related activity Ensuring compliance to cGMP Prepare Annual Training Plan in co-ordination with Head of QA Schedule and coordinate the cGMP training session Assist in the delivery of new employee orientation training Assure training records are maintained for regular, temporary and contractors/consultants Check monthly log book and calibration of IPQA instrument and balance Stability and control ...

Sr Production Officer -3-10Years in Effervecscent Tablets-Granulation, Compression and Coating plan,CGMP etc with salary pack of upto 7LPA and Dahej Location.

Hii, Greetings from Avaniconsulting ! We are hiring for Warehouse Associates for a leading Pharma API Manufacturing company Experience - 5-8 years location- Mysore RESPONSIBILITY : 1) Adherence to CGMP (current good manufacturing practices) and safety practice. 2) Responsible to prepare the Departmental SOPs and ensure the effective implementation. 3) Responsible to improve of the QMS activities as per the requirements. 4) Daily Monitoring and record of environmental condition in warehouse. 5) Maintaining housekeeping in warehouse. 6) Updating of all logbooks and record as per SOP. 7) 100% Compliance in QMS and EHS by following the SOPs. 8) Ensuring materials segregation in both RM and PM wi...

Job Description : Execution of reaction on day to day basis and support to seniors and plant Responsible of handling / maintenance of lab equipment's Strict adherence to cGMP norms and safety rules of the company Responsible for complete documentation of reaction and reaction associated therewith. To ensure calibration of lab equipment's Intellectual contribution towardsnew ideas pertaining to the reaction and project To be a part of the team and work towards successful and timely execution of projects. Adherence to GLP practices. To collaborate with cross functional teams wherever required To prepare weekly update and final reports

As a Water and HVAC Systems Operator, your primary responsibility will be to efficiently operate and manage the water and HVAC systems in accordance with Standard Operating Procedures (SOP). You will also be in charge of maintaining an inventory of critical spares and chemicals for these systems to ensure smooth operations. Additionally, providing necessary utilities such as Raw water, RO water, WFI, Purified water, pure steam, Compressed air, and Nitrogen to the production department or other users will be part of your daily tasks. Key Responsibilities: - Recording and updating all water and HVAC system data as per SOP guidelines, while adhering to cGMP and GEP standards in all work activit...

In this role as the QC Head at our company in Ankleshwar, Gujarat, you will be responsible for ensuring the quality of all manufactured batches. Your main tasks will include overseeing the Quality Control department's functions, managing quality assurance activities, and conducting various tests to ensure materials and products meet specifications for release or rejection. Your key responsibilities will include: - Sampling, inspection, and testing of raw materials, packaging materials, in-process products, and finished products according to specifications - Overseeing stability testing, chamber handling, and evaluating product shelf-life - Conducting microbiological analysis, reviewing trend...

Job Description Roles and Responsibilities Operate as part of the QC team according to Company safety policies and cGMP to drive compliance with our company's Global policies, procedures, guidelines and regulatory requirements in the performance of all applicable job functions. Complete all documentation in compliance with cGMP and GxP standards. Perform receipt and release of all materials ensuring QC Right First Time and turnaround time KPIs are achieved. Review of all vendor and external laboratory documentation associated with receipt and release of materials to ensure compliance with internal specifications and Pharmacopeia. Maintain clear, accurate records associated with all day to da...

Utility Operator HVAC / Water / Electrical (01 Position) based in Vapi, Gujarat. The ideal candidate brings 5 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 improvemen...

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 (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

The ideal candidate brings 5 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) Own production execution and shift supervision; ensure line clea...

The ideal candidate brings 3- 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/Kaizen). Own production execution and shift supervision; ensure lin...

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...

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 10- 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 microbiology practices including EM, MLT, sterility ...

The ideal candidate brings 2 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 QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA,...

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 (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

Production Executive 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). Own production executio...

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...

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...

Senior Officer QA (QMS) 1 Post based in Kathua, Jammu & Kashmir. The ideal candidate brings 4 - 6 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...

Chemist (On Contract) (MP 25/20) 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 (5S/Lean/Kaizen...

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)...