244 Oot Jobs - Page 2

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...

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/...

As a Review Analyst at Piramal Pharma Solutions (PPS) located in Digwal, your role will involve reviewing analytical reports and handling investigation incidents. You will be responsible for the following key responsibilities: - Review in-process analytical data before release - Review intermediates, stability batches, and finished products analytical data - Knowledge on analytical method validations and method transfers - Review system audit trails for all types of instruments in QC - Review calibration data of instruments on a daily basis - Verify SOPs compliance on the shop floor - Conduct audits for laboratory system compliances as required - Investigate incidents, OOS, OOT, and root cau...

Initiate and conduct investigations associated with sterile injectable product manufacturing and processing. To identify true root causes through different tool and identify SMART CAPAs. Review of investigations to ensure content of report in compliance to the site procedure requirements for its completeness, accuracy and adequacy. To investigation market complaints, identify the root causes and respond to partner/customer. To monitor overall investigations matrixes and present to management time to time. Responsible for Quality compliance within the investigation process. Actively involved in regulatory audits as a process SME. Provide management timely updates on critical events. To sustai...

Job Title: Deputy Manager- Formulation Location: Govandi, Mumbai Department: Corporate Quality Assurance Qualification, Experience and Technical Competency: 1. Master’s Degree in Pharmacy or Science or equivalent scientific field. 2. Minimum 10 years experience in Pharmaceutical Industry (Strong background of Formulation industry with 2 to 3 years experience in Quality Control.) 3. Work experience in Regulatory Sites (USFDA, MHRA, EU GMP) 4. Knowledge of current Good Manyfacturing Practices (cGMP), Quality Management Systems (QMS) and regulatory guidelines. Key Requirements: Responsible for Quality Functions across Own Sites and Contract Sites with adherance to cGMP, Regulatory standards and...

Review of daily coordination activities related to Quality Compliance for products recalls and change control. Investigation of Market Complaints. Interaction with R&D for technology transfer and Analytical Method Development. Release and Rejection of Raw Materials, Packaging Material, Intermediates and Finished Goods. Identification of the training needs of all the individuals and referring if to personnel Department. Validation of Analytical Method, Process and Cleaning Preparation of Protocol & Specification for Finished Product, Raw Materials Packing Material & Stability samples. Maintenance of quality control instruments Ensure systems are in place including appropriate documentation an...

Role & responsibilities Complete Analysis of various raw materials, In-process, Drug substance and finished Products in line with Pharmacopeia method and in-house Specification and test procedures. Change Control, Deviation, Root Cause investigation, CAPA, OOS, OOT, Incidence Calibration of Instruments HPLC , UV-Visible Spectrophotometer, pH Meter,KF Titrator, weight balance. Working standard preparation as per SOP. Ensure the timely analysis of samples GLP, GMP, GDocP (With respect to Regulatory Guidelines) Function in details of various Section of QC/QA(Eg.Raw Material, Finished Product,Stability Study etc. Data Integrity 21 CFR Part 11 Qualification, Calibration, Validation. Maintaining t...

Key Responsibilities : 1. Documentation & Compliance Ensure compliance with cGMP, WHO, EU GMP, USFDA, and other regulatory requirements specific to injectable formulations. Review, control, and maintain SOPs, Quality Manuals, and other QMS documents. Control issuance, retrieval, and archival of GMP documents as per SOPs. 2. Deviations & CAPA Investigation and documentation of deviations, incidents, and non-conformances. Identify root causes using tools like 5 Whys / Fishbone analysis. Initiate, track, and ensure timely closure of Corrective and Preventive Actions (CAPA). 3. Change Control Review and manage Change Control records related to injectable manufacturing. Ensure impact assessments ...

Coordinate with vendors for production planning, track POs, ensure OTIF delivery, monitor costs, maintain D2S timelines, conduct quality checks, reduce OOS %, and collaborate with sourcing, production & accounts teams.

Responsibilities: Analytical Operations: Perform and supervise analysis of Raw Materials (RM), Packing Materials (PM), and Finished Goods (FG). Operate and maintain analytical instruments :- HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus Ensure compliance with GLP, 21 CFR Part 11, and data integrity standards. Review and approve analytical reports and LIMS entries , Quality Systems & Compliance Implement and monitor Quality Management Systems (QMS). Lead investigations for OOS, OOT, Deviations, and Laboratory Incidents. Prepare and review SOPs, STPs, and validation protocols. Ensure audit readiness and support regulatory inspections (USFDA, WHO-GMP, etc.) Documentation & Reporting Maintain ac...

Responsibilities: Lead and oversee the entire Quality Control department operations. Ensure compliance with cGMP, regulatory guidelines, and company quality standards. Review and approve analytical methods, specifications, and validation protocols. Supervise raw material, in-process, and finished product testing. Ensure timely release of batches and materials. Manage laboratory investigations, OOS, OOT, deviations, and CAPA. Coordinate with QA, Production, and Regulatory teams for smooth operations. Handle audits (internal, external, and regulatory) and ensure readiness at all times. Provide training, mentoring, and performance evaluation of QC staff. Drive continuous improvement, cost effic...