146 Cleaning Validation Jobs - Page 2

As a Manager Quality Assurance at Syngene International Ltd., you will be responsible for ensuring compliance with all national and international regulatory agency requirements related to API manufacturing. Your role will involve evaluating and approving vendors/subcontractors, reviewing and approving various reports such as SOP, analytical method validation, and calibration reports, and coordinating review meetings to maintain the effectiveness of the quality system. You will be expected to have a strong understanding of regulatory requirements from agencies such as ICH, USFDA, WHO Geneva, PMDA Japan, and others. Additionally, you will play a key role in the approval of protocols and report...

Job Title: Manager Quality Assurance (QA) Company: Global Calcium Pvt. Ltd. Location: Unit III – Hosur, Tamil Nadu Experience: 10+ years Qualification: B.Pharm / M.Pharm / M.Sc or equivalent Job Description: We are looking for an experienced Manager – QA to lead our Quality Assurance team at Global Calcium Pvt. Ltd., Unit III (Hosur). Key Responsibilities: Lead Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements. Manage validation and qualification of equipment, utilities, and processes. Ensure audit readiness and compliance with regulatory agencies (USFDA, EU, WHO, MHRA). Review and approve SOPs, protocols, and reports related to validation and qua...

1. Quality Systems & Documentation: Develop, implement, and maintain GMP-compliant QMS. Oversee change control, deviations, CAPA, incident management, risk assessment, and market complaints. Ensure GDP compliance in all QA documentation, including SOPs, batch records, specifications, and MOAs. Prepare and revise SOPs, distribute and retrieve old versions, and manage documentation control. Handle QMS activities like return goods, non-conformities, and investigation reports (5-Why, 6M method). 2. Validation & Qualification: Review and approve URS, IQ, DQ, OQ, and PQ protocols and reports. Manage process validation, cleaning validation, equipment qualification, and facility validation. Conduct ...

We are looking for a meticulous Sr. Executive - Production to spearhead production activities and ensure adherence to stringent quality standards at Synnat Pharma Private Limited. As Sr. Executive - Production, you will play a pivotal role in managing batch manufacturing records, equipment compatibility, and various validation protocols, including process, cleaning, blending, drying, and micronization. The ideal candidate will be adept at preparing master formula records, quality equivalence reports, and standard operating procedures, while also taking the initiative for change controls and performance qualifications. This role demands a strong understanding of QMS activities, internal and e...

Dear All, Greetings from Aizant Drug Research Solutions!! We are looking for a motivated professional with strong expertise in Cleaning Validation (QA Formulations) to join our Quality Assurance team. The ideal candidate should have hands-on experience in planning, executing, and documenting cleaning validation activities as per regulatory requirements. Experience: 3-5 Years Location: Hyderabad(Dulapally) Department: Quality Assurance(Formulations) Key Responsibilities: -Preparation and review of Cleaning Validation protocols, reports, and risk assessments. -Execution and monitoring of Cleaning Validation studies as per cGMP guidelines. -Identification of worst-case products and development ...

You should possess a B. Pharmacy/M. Pharmacy (Pharmaceutical Analysis and Quality Assurance) or M. Sc. in Chemistry or equivalent with 5 to 8 years of experience in formulation pharmaceutical industries in the quality control department. In this role, you will be responsible for handling day-to-day activities related to sampling, testing, and release of active ingredients, inactive ingredients, packaging materials, in-process and finished products, stability samples. Your primary responsibilities include ensuring that all activities within the quality control section meet current applicable cGMP guidelines and regulatory expectations. You will be accountable for ensuring timely sampling, ana...

We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Spe...

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/...

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/...

Senior Executive QA 1 Post based in Kathua, Jammu & Kashmir The ideal candidate brings 8-10 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) S...

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...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Method verification/validation of compendia/pharmacopeial updations, Method ve...

Role & responsibilities Complete knowledge of Validation ( AHU / Autoclave / Dry Heat Sterilizer etc ) and Calibration -Capable of Compiling the Validation and calibration Activities -Good Computer Skill Preferred candidate profile CLEAN SHAVEN MALE CANDIDATE WITH MINIMUM 2-3 YEARS EXPERIENCE IN STERILE INJECTION SECTION

As a Quality Assurance Specialist, your responsibilities will include reviewing all Master Production and Control Record (MPCR) and Batch Packing Records (BPR), as well as Standard Operating Procedures (SOPs). You will need to meticulously review specifications and testing procedures for starting materials, packaging materials, in-process products, finished products, working standards, and stability (Shelf life). Additionally, you will be tasked with reviewing Out-of-Specification (OOS) investigation reports and participating in investigations related to complaints, vendor audits, external testing laboratories audits, and the subsequent Corrective and Preventive Actions (CAPA). You will also...

Treasury Treasury at Deutsche Bank is responsible for sourcing, managing, and optimizing Deutsche Bank's financial resources and providing high-quality steering to the Bank on financial resource deployment. Treasury's fiduciary mandate encompasses the Bank's funding pools, asset and liability management (ALM), liquidity reserves management, and supporting businesses in delivering their strategic targets at the global and local levels. Further, Treasury manages all financial resource optimization to implement the group's strategic objective and maximize long-term return on average tangible shareholders' equity (RoTE). The current role is part of the Treasury Office in Mumbai. The position req...

Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies ...

Purpose of Job 1. Preparation and Review of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Having basic knowledge on Microsoft Word and Microsoft Excell 2. Have knowledge of Minitab software for statstical evaluation of data. Roles and Responsibilites 1. Preparation and review of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern depa...

Purpose of Job 1. Preparation of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Utilization of Microsoft Word and Microsoft Excell 2. Using of Minitab software for statstical evaluation. Roles and Responsibilites 1. Preparation of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same. Quali...

Roles and Responsibilites 1.In process Quality Assurance activity in Production and warehouse area 2.Provide line clearance as per SOP 3.Monitoring and QA rounds in production and Warehouse 4.Sample verification against TRF / BPCR 5.Carry out Semi-finished / finished product sampling for release, stability study and control samples 6.To send samples along with TRF to Quality control laboratory 7.Participate in media fill, process validation, cleaning validation activities as per requirement 8.Timely communication and co-ordination with all the stake holders 9.Participation in Change control, Deviation & Investigations as per requirement 10.Preparation / review of documents like; SOPs, risk a...

Front-office Operations project site, Supervise client-facing staff including front desk, Sales support, Coordinators, Client visits , Schedule marketing collaterals, Project materials, lead data, Visitor reports, Customer queries, Sales, Marketing.

You will be responsible for conducting line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. Additionally, you will perform environment monitoring activities and ensure compliance with cGMP at the shop floor. Your role will involve process validation, cleaning validation/verification, hold time study, media fill, routine batch sampling, and in-process testing at different stages according to batch documents and SOPs. You will review executed BMRs, BPRs, environment monitoring data, water trends, printouts (CIP, SIP, autoclave, filter integrity), and different types of planner and calibration certif...

Job Title: Quality Assurance Officers (4 Positions) Company: Nourish Pharmaceutical Pvt Ltd Location: Kheda, Gujarat Job Type: Full-time Nourish Pharmaceutical Pvt Ltd is a leading pharmaceutical company committed to delivering high-quality products. We're expanding our Quality Assurance team and looking for talented professionals to join us. Positions: 1. Quality Assurance Officer - Production 2. Quality Assurance Officer - QMS 3. Quality Assurance Officer - Validation & Qualification 4. Quality Assurance Document Control Officer Job Descriptions: 1. Quality Assurance Officer - Production - Key Responsibilities: - Ensure cGMP compliance in production areas - Manage and review Batch Manufact...

Job summary We are looking for an individual to perform filling/washing and sterilization operations within GMP (Good Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines, ensuring compliance with quality standards, GMP, and regulatory requirements as per schedule. Roles & Responsibilities - Perform filling, washing, sterilization operations as per the day plan, executing batch production records. - Participate in filling area line clearance activities and perform machine cleaning operations. - Handle material dispensing and issuance from the warehouse. - Issue discrepancies, work with cross-functional ...

Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA closure of the same before the product release. Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities within the due date. Coordinating for complaint investigation, handling of Return Goods and Recall. Review of contract manufacturing / testing documents such as, executed BPR and Analytical reports. Shall be responsible for performing unplanned audit on shop floor. Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident. Shall be responsible for review and closure of Change ...

Position : Executive Engineering QMS Qualification : BE Mechanical/ Electrical/ Instrumentation or B pharma preferably BE Experience : 6-7 years experience in handling engineering department GMP documentation activities and supporting engineering function as SME in QMS documentation Responsibilities : 1.Implementation of quality assurance standards, processes, controls and cGMP in warehouse. 2. Preparation of SOPs and ensure effective implementation. 3. should be well versed with deviation management SOP 4. Should be well versed with change control and CAPA management related to engineering department 5. Should be familiar with documentation like DQ, IQ, OQ and PQ. 6. To ensure that training...