311 Oot Jobs - Page 4

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...

Walk-In Interview Date : 02nd November 2025 (Sunday) Timing : 9.00 AM to 2.00 PM Venue : Umedica Laboratories Pvt, Ltd. Plot No 221,221/1 II Phase GIDC Nr Morarji Circle, Vapi 396195. 1. Tablet Manufacturing Department: Ability to handle process like Dispensing, Granulation, Compression, Coating, SOPs preparation, well versed with ALCOA & GDP principles. QMS Manufacturing investigation (OOS/OOT/Deviation/CAPA),Training.) Position: Officer to Sr. Executive Qualification: M.Sc. / B.Pharm / M.Pharm No. of Vacant Position: 10 Experience: 2 to 8 years To Operate Granulation lines (RMG/FBD/FBP/Roll Compactor), Automatic Compression Machine (PLC/SCADA based Cadmach & Fluid Pack), Coating (Kevin & G...

Key Responsibilities: Preparation, review, and control of Master Formula Records (MFRs) and Batch Manufacturing Records (BMRs). Identification, drafting, review, and periodic revision of Standard Operating Procedures (SOPs) across departments. Compilation and preparation of Annual Product Quality Review (APQR) reports. Preparation, review, and execution of Qualification & Validation documents (equipment, utilities, process, cleaning, etc.). IPQC management ensure in-process checks are conducted as per defined procedures and documented appropriately. Ensure timely product release as per defined process and quality requirements. Work on company-wide quality strategies aimed at reducing non-com...

Job Description -Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished products for US and IRF market at CMU. -Release of batch manufactured for US and IRF market at CMU -Handling of market complaint with root cause identification and CAPA implementation -Review of documents such as executed BPR, Analytical records, Change Controls, Deviations, OOS, Process Validation, Cleaning Validation, Equipment Qualification, stability data and CAPA for products of US & IRF market. -Provide required documents to Regulatory affairs for variations and updates -Monitoring of process st...

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...

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...

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 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...

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...

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/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 5-8 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/...

Issuance of Analytical Data Sheets and Formats. Preparation and Review of specification and standard test procedure. Review of QC Analytical Data. To ensure online documentation in laboratory as Good Documentation Practices. To attend training as per refresher training schedule. To ensure all time audit readiness in the work area. To perform any other work as and when assigned by Head of department.

1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...

Role: Documentation Department: Production Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal oppor...

Analytical test including physical and wet analysis. Expertise in handling of HPLC, GC , UV and IR Knowledge on OOS and OOT Calibration of laboratory Instruments. Preparation and standardization of Reagents/Volumetric solutions. To ensure cGLP compliance and Data Integrity

The opportunity Senior will play a critical role in managing a team. Work closely with clients of People Advisory Services within and outside EY Your key responsibilities Responsible for executing, quality control and reporting daily status to the internal leadership team as well as to our user groups Responsible for meeting contractual SLA's Will be the first point of escalation Adhere to practice protocols and other internal processes consistently Be an integral part of the Global and/or Local Client Service Delivery team Conduct complete review of client deliverables for quality assurance and ensure the team has adhered to the process protocols. Handle escalations effectively Develop a hi...

Exciting Career Opportunities at Natco Pharma Limited for the following requirements Open Positions: Operators & Supervisors OSD Production & Packing (Onco & Non-Onco) Experience: 0 to 8 Years (Freshers graduated in 2024/25 are eligible) Qualifications: I.T.I / Diploma / B. Pharmacy Key Responsibilities: Operate equipment's in Granulation (RMG, FBD, ACG, GEA), Compression (GEA, Sejong), Coating (NEOCOTA), Capsule Filling (Bosch, MG02), Blister Packing (CAM NMX, HV1, BQS, IMA/ACG), and Bottle Packing (CVC, Optel) lines. Supervise production lines, including Granulation, Compression, Coating, and Packing (Blister/Bottle). Good verbal and written English communication skills 2. Operators & Supe...

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...

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...