148 Oot Jobs

To ensure the GMP and GLP compliances. To participate in OOS, OOT, Deviation and complaint investigation, root cause analysis and to review investigation report. To carry out closure activities. To compile data provided by manufacturing, warehouse, QC for preparation of complaint investigation report. To prepare and review trends of OOS, OOT, Deviation, complaints, customer audit/inspection. To initiate change controls pertaining to QA and to review change controls of other departments w.r.t impacted activities. To review change control trend. To compile data for and prepare, review risk assessment reports w.r.t. Deviation, OOS, OOT, Nitrosamine impurities, elemental impurities, etc. To approve SOP preparation request, print request, training tasks, document publish request of all departments in Caliber Software. To review SOPs of all departments in Caliber software. To approve specification, STP and TDS preparation request, training tasks, document publish request of all QC department in Caliber Software. To assist conduction of customer audits and regulatory inspections. To verify the audit/inspection preparedness. To compile data and prepare the customer audit/ regulatory inspection compliance report. To convey the audit observation and activities planned for compliance along with TCD to respective departments. To perform internal audits of departments as per schedule. To compile data and prepare QRM report, presentation. To prepare minutes of meeting of QRM and convey the action plan with all departments. To prepare LOA and LOC as per requirement of customer and to assist in market response and queries. To evaluate change controls w.r.t regulatory impact. To compile data for DMF preparation of US, EP and ROW grade. To review protocols and reports of process validation, cleaning validation, general study, etc. To review vendor questionnaires.

Role & responsibilities Suggested position: Sr Manager / Manager Education: Post Graduation (Life sciences preferred) Total Exp: 15-17 Years (Biopharma is preferred) Others: Ready to support in different shifts Responsibilities: Mainly responsible to review of Harvest, Drug Substance and Drug Product analytical (Biosimilars) raw data and analytical trends Conduct Gemba walkthroughs in QC department and to ensure quality compliance. Involve in investigations (Deviations, OOS, OOT, Lab incidents) to ensure QMS compliance for QC sections Audit trails and conduct routine monitoring in QC to check effectiveness of the system implemented. Responsible for preparation and review of documents SOPs, Protocols, Reports, Trends, APQR, Annual trends etc Track Reference standards related studies and review of related documentation timely

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

Role Overview: As a Manager in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac), your role will be critical in handling in-process Quality Assurance functions. You will ensure that defined and approved IPQA checks are followed and documented during Dispensing, Manufacturing, filling, capping, and Packing stages. Your responsibilities will include ensuring compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing. Additionally, you will review Smoke study protocol, report, and Video recording, and participate in regulatory audits. Key Responsibilities: - Handle in-process Quality Assurance functions by ensuring compliance with defined IPQA checks during various stages of manufacturing - Ensure compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing - Review Smoke study protocol, report, and Video recording, and authorize final document approval in the absence of Head Quality Assurance - Participate in regulatory audits and ensure compliance - Review and approve Process validation, cleaning validation, aseptic process simulation protocol, reports, change control, deviation, incident reports, OOS, OOT, non-conformance, and CAPA in consultation with Head Quality Assurance Qualifications Required: - M. Pharm/B. Pharm qualification - 15 to 17 years of experience in the pharmaceutical industry - 03 years of experience at Zydus - Knowledge and experience in an injectable plant Please email your CV to isha.naik@zyduslife.com for consideration.,

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 Upload) Knowledge on CSV methodologies. Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. During OneERP deployment: Be the 1st point of contact for the OneERP project team in their assigned domain. Participate and contribute several deliverables during the OneERP deployment. Ability to make decisions on future system capabilities, and/or manage decision making process within local stakeholders. Participating in UAT and eventually accepting the new system in the assigned domain. After One ERP deployment: Are an advocate of SAP to their organization/department. Lead training to new and existing Users Learn and pass on key information to their Users about SAP and SOPs Act as an initial point of contact in identifying and managing any concerns Users have with accessing or navigating SAP. Can create ServiceNow incidents when they are unable to resolve a problem after checking with the Global Power User and available support resources. Support resolution of ServiceNow incidents Obtain additional training to further their knowledge of SAP. Strong IT skills: MSOffice (Excel) and SAP/Oracle are a must

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 Upload) Knowledge on CSV methodologies. Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. During OneERP deployment: Be the 1st point of contact for the OneERP project team in their assigned domain. Participate and contribute several deliverables during the OneERP deployment. Ability to make decisions on future system capabilities, and/or manage decision making process within local stakeholders. Participating in UAT and eventually accepting the new system in the assigned domain. After One ERP deployment: Are an advocate of SAP to their organization/department. Lead training to new and existing Users Learn and pass on key information to their Users about SAP and SOPs Act as an initial point of contact in identifying and managing any concerns Users have with accessing or navigating SAP. Can create ServiceNow incidents when they are unable to resolve a problem after checking with the Global Power User and available support resources. Support resolution of ServiceNow incidents Obtain additional training to further their knowledge of SAP. Strong IT skills: MSOffice (Excel) and SAP/Oracle are a must

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, EBMR, BPCR, MPCR, TTD, PTN, Protocol, Report and QMS documents of BBM, MSAT and R&D). - Review of Change Controls, CAPA, Deviations, OOT, OOS and related transactions in respective software. - Preparation and Review of APQR related to CI and DS. - Responsible for Handling and review/assessment of FMS Alarm, Equipment Breakdown, SAP Incident and ERN (Error Ratification Notification) Handling. - Responsible for approval of material request from various user departments related to BBM facility. Responsible for approval/authorization of user access request related to BBM facility. - Review of Electronic record and Audit trail related to equipment/systems of BBM Facility. - Responsible for verification of BOM in SAP. Responsible for doing transactions related to BPCR review and Interim batch release in SAP. Responsible for QMS notification creation in respective software. - Responsible for EBMR/ E-Logbook Data creation, modification In SAP. Responsible for linking BOM with the effective MPCR in case of EBMR in SAP. - Monitoring and participation in Process Validation/Cleaning Validation activities of BBM. Review and compilation of Process Validation/Cleaning Validation documentation. - Participation in internal/external audits. - Preparation and review of the documents related to the quality assurance - Responsible for providing required document support to RA, R&D and DQA. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.

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 processes effectively. Your skills in handling documentation, including preparing and maintaining Site master files, Master Validation Plans, and Batch Manufacturing Records (BMRs), will be essential in maintaining accurate records. As part of your responsibilities, you will conduct stability studies and manage stability programs. Additionally, you will be responsible for effectively managing Out of Trend (OOT) and Out of Specification (OOS) results. Adhering to current regulatory guidelines and Pharmacopeial revisions will be a core aspect of your role. You will evaluate deviations, manage change controls, and implement corrective and preventive actions (CAPA) to address any issues effectively. Overseeing the calibration of equipment and adhering to regulatory standards such as ICHQ7A guidelines will be part of your daily tasks. Conducting trend analysis, implementing Quality Risk Management strategies, and working towards continuous improvement of quality systems will be key aspects of your role. Efficiently managing Quality Control departments and ensuring data integrity will be crucial in this position. Your experience in handling ISO documentation procedures and managing sampling and testing of excipients, Essential Oils, and Aroma chemicals will be valuable. Strong skills in managing manpower effectively, along with effective oral and written communication skills in English, will be necessary for success in this role. If you have a minimum of 5 years of experience in Quality Assurance and a total of 5 years of work experience, this full-time position in person may be the perfect fit for you.,

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 Regulated/Semi-regulated markets. Should be familiar with quality systems followed in the analytical Laboratory Educational Qualification: M. Sc. Chemistry/Analytical, B. Pharm, M. Pharm Salary: No bar for appropriate and early joining candidates Please bring following documents (Mandatory) 1) Updated CV 2) A color passport size photograph 3) Original and photo copies of all educational certificates, 4) Aadhar card, 5) PAN card 6) Salary slips of last 3 months. Please call on us on 04344-277937, 276618, for any queries. I f you unable to attend Walk-in interview, Send your updated CV to manjula.m@microlabs.in

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/Kaizen). Additional info: Key Skills: IPQA, Vendor Qualification, Analytical QA Qualification: M.Pharm / B.Pharm / M.Sc Experience: 5 to 8 years Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

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). Manage QC lab workflows: RM/PM/FG testing, HPLC/GC operations, stability studies, instrument calibration/qualification (IQ/OQ/PQ), and review of analytical reports and CoAs.Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

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/Kaizen) Additional info: Key Skills: Area Qualifications, Calibrations, MLT, BET & Water Analysis Qualification: M.Pharm / B.Pharm / M.Sc Experience: 5 to 8 years Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ ERP/ LIMS is a plus

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/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO) Additional info: Venue: Seminar Hall, Godavari Institute of Pharmacy, Kolpa, Latur Eligibility: D.Pharm & B.Pharm Students Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus

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/Kaizen). Additional info: Key Skills: Method Development, Validation & Documentation Experience: 5 to 8 years Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/ LIMS is a plus.

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 QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO). Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

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). Maintain utilities: HVAC, purified water/Clean Steam/Compressed Air systems; execute preventive maintenance, breakdown analysis, and qualification; ensure aseptic support and energy efficiency. Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

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 improvement (5S/Lean/Kaizen). Additional info: Key Skills: Inventory Management, GMP Compliance, Sampling, Dispatch, Hazardous Store Handling Experience: 5 to 10 years Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

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 microbiology practices including EM, MLT, sterility assurance, water/air monitoring, microbial ID/trending, and method validation; establish contamination control strategy and support media fills and aseptic behaviors. Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.