700 Oos Jobs - Page 2

Role & responsibilities : Responsible for investigation of incidents, OOS, OOT, OOC & Deviation in Laboratory. Responsible for Review and closure of investigation of incidents, OOS, OOT, OOC & Deviation in Laboratory. Responsible for initiation & closure of Change Control, Deviations, CAPA in QEdge Software. Responsible for Review of Standard Operating Procedures and Standard Test Procedures. Responsible for preparation of Protocols, Reports and Annexures Investigation & Documentation. Responsible for Review of analytical documents, and audit trials as per 21 CFR part 11 compliance. Deep understanding of GMP, GLP, ISO 17025, regulatory guidelines, QMS, HPLC, GC, data integrity. Preferred can...

Greetings of the day ! Our reputed MNC Client is hiring for: Position: Production Documentation Location: Unit-1 is situated at Bonthapally village in Medak District, ( Hyderabad) Transport is available Notice Period: Immediate/ 15 days/ 30 days Shift: Day Shift ( Rotational Shifts ) Work Mode: 6 days working ( Work From Office ) Interview Mode:- F2F for Hyderabad candidates Virtual interview for outstation candidates Job Description Role : (Chemist / Officer) , Production Documentation. Education Qualification: B . Sc / Diploma Chemical / M.Sc Experience Required: 3-6 years. Roles & Responsibility : Having good knowledge in QMS, OOT, OOS, Deviation, CCF, Validation, process validation, clea...

Quality management System, Injectables ; Production QMS

Roles and Responsibilities Conduct analytical testing of finished products, including dissolution, UV-Vis, KF, FTIR, and GLP compliance. Develop and validate analytical methods for solid oral OSD products using techniques such as GC, HPLC, and UV spectroscopy. Perform method transfer and validation activities to ensure accuracy and reliability of test results. Collaborate with cross-functional teams to resolve OOS/OOT issues and implement corrective actions. Maintain accurate records of laboratory data, reports, and documentation in accordance with cGMP guidelines.

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : IT Infrastructure Operations Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Position Summary The IT Infrastructure Architect will design, implement, and optimize enterprise-level solutions across Operating Systems, Databases, Site Reliability Engineering (SRE), and Middleware platforms. The role requires deep technical expertise, strategic planning, and leadership to ensure high availability, scalability, performance, and s...

NATCO Pharma is hiring! Join us for a walk-in interview on 06th December 2025 in Chennai across key functions: Maintenance, Production, EHS, QA, QC & Microbiology. Be part of a team that is committed to quality, innovation, and excellence in API manufacturing. Job Requirements Maintenance - Utilities / Mechanical / Electrical / Instrumentation Qualification: DME / B.E (Mechanical / Electrical / Instrumentation ) Operator: 3 to 5 yrs (Utilities Water Systems, AHUs, Compressors, Chillers, Boilers) Supervisor: 7 to 10 yrs (Process & Utility Equipment Maintenance, GMP Documentation) Instrumentation Operator: 2 to 3 yrs (Calibration, Automation) Electrical Operator: 3 to 5 yrs (HT/LT Operation, G...

As the Quality Management Systems Specialist, your role will involve initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. Additionally, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your responsibilities. Key Responsibilities: - Initiate, review, and approve quality management systems including Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints - Handle Return Goods and perform risk assessments to ensure the proper functioning of the qualit...

The QMS Lead / Head is responsible for establishing, implementing, and maintaining a robust Quality Management System in compliance with USFDA, WHO , and other global regulatory requirements. The role ensures that vaccine manufacturing operations meet applicable GMP standards, inspection expectations, and quality risk management principles Key responsibilities: Lead implementation, maintenance, and continual improvement of the site QMS in alignment with ICH Q10, WHO TRS, and USFDA 21 CFR Parts 210/211/600. Ensure continuous inspection readiness for WHO-PQ , USFDA , EMA , CDSCO , and other regulatory agency audits and Lead preparation of inspection plans, SME readiness, and gap assessments. D...

Review BMR/BPR/SOP, ensure GMP compliance, control and archive documents, support audits, handle deviations/CAPA/change controls, ensure data integrity, coordinate with Production/QC for timely documentation, compliance checks & ongoing improvements.

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...

About The Role Job Title - Internal Audit Analyst Management Level :11 – Analyst Location:Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary :An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You ...

Job Title: IT Projects Implementation team member Business Unit: Tandalja Job Grade Sr. Executive IT- G11B Location: Tandalja At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Lead assigned rol...

Job Title: Sr.Manager (QA-QMS) Business Unit: Global Quality & Compliance Job Grade G9B Location : Poanta At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Investigation and overall handling of ...

Candidate should be competent to handle the assigned activity related to analytical method validation (Test Related substances, Assay, Residual solvents Force degradation), Finished API on HPLC, GC GCMS System as per standard operating procedures. Documentation practices as per GLP and GDP requirements. Candidate should have good learning ability, technical knowledge good analytical skill

To ensure cGxP in laboratory. Sampling of Raw materials and packaging material samples. To carry out all the activities related to LIMS as per job assigned. Disposal and destruction of retain samples as per procedure. To ensure proper handling and cleaning of related lab instrument. Ensure Safety and good documentation practices in QC. Proper disposal of used materials, carry it to ETP for discard.

Job Title: Manager / Sr.Manager – API Cluster Support (QA) Business Unit: Global Quality & Compliance Job Grade G10 / G9B Location : Mumbai At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Summary : The Senior M...

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 Responsibility: Quality Management System (QMS) Activities: Oversee and perform all Quality Management System (QMS) activities for the Quality Control Microbiology department. Conduct and review investigations related to microbiological laboratory OOS/OOT, environmental monitoring deviations, and sterility failures. Identify root causes and recommend corrective and preventive actions (CAPAs). Ensure timely closure of laboratory deviations and maintain thorough documentation. Lead the preparation, review, and approval of QMS documentation, including change controls, risk assessments, and quality records. Perform and oversee the preparation and review of documentation related to microbiolo...

Key Responsibility: Manufacturing Oversight: 1. Shop Floor Oversight: Monitor and oversee sterile injectable manufacturing activities on the shop floor to ensure adherence to cGMP, SOPs, and regulatory requirements Provide real-time guidance and decision-making during production to ensure product quality and compliance 2. Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) Prepare, review, and approve BMRs and BPRs to ensure accurate documentation and compliance with manufacturing procedures Ensure completeness, accuracy, and timely review of all manufacturing records 3. In-Process Quality Checks: Perform in-process quality checks during manufacturing stages to ensure critical ...

Key Responsibility: Validation Activities: 1. Media Fill Studies: Plan, execute, and review media fill trials to ensure aseptic process integrity. Analyze results and recommend corrective actions when necessary. 2. Area Qualification: Oversee qualification of classified manufacturing areas (Grade A-D). Perform routine re-qualifications and environmental monitoring to ensure regulatory compliance. 3. Equipment Qualification: Develop and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of manufacturing equipment. Review and approve qualification documents. 4. Utility Qualification: Validate critical utilities such as HVAC...

Job title ADL executive Division phrama Function Analytical method validation Location dombivali Designation ADL executive Job Grade Reporting to (position) ADL Head Direct Reportees (Nos) Company Name Aart industries limited Key Role & Responsibilities 1)Able to performed method validation on GC HS 2)analytical method transfer 3) Able to performed method validation on GCMS 4)method development on GC 5)Handling incident and deviation 6) online review of system,log books 7)Aware of 21 CFR part 11 guidlines ICH and Anvisa Guidlines 8) GC MS and LCMS Linkages within / outside the organisation Internal External Job specification Experience min 9 years Qualification MSc CTC Range as per company b...

Role & responsibilities 1.Involved in preparation, review and approval of documents related to Quality control includes COA,STP, SPE, DRS, MOA, SOP, and Protocol. 2. Ensure timely analysis and release of RM/PM/CM, DS, DP, IPQC samples, Plasma samples. 3. Ensure the operation, calibration, maintenance, qualification, validation of instrument as per the defined procedure. 4. Ensure reference Standard / Working Standard Management and control. 5. Review of Log Book, Calibration Records and Volumetric/Test Solutions Records but not limited to as when required. 6. Co-ordination with cross functional team like QA, Production, Engineering, Purchase, Finance, Regulatory, ADL/R&D, IT, HR as when requ...

Senior Manager 1

As an Assistant Manager Quality Control at Cadchem Laboratories Ltd., your role involves ensuring the adherence to all GxP activities in the laboratory. This includes overseeing the timely calibration and preventive maintenance of laboratory instruments. You will also be responsible for providing training on the operation and calibration of instruments/equipment in the Quality Control department. Your active participation in handling OOS/OOT deviations, customer complaints, and reviewing/approving specifications, STPs, and SOPs is crucial for maintaining quality standards. Your duties will extend to coordinating with external laboratories for testing, vendors for timely AMCs/CMCs of laborato...

QA tasks including document control, archival, COA prep, SOP creation, audits, training, deviation review, raw material checks, QMS/DMF/SOP prep, batch allocation, MIS data, and support for client/regulatory audits ensuring cGMP/GLP compliance. Perks and benefits Bachelor's accommodation and Travelling