50 Bmr Review Jobs

Oversee QA For Contract Manufacturing: Draft Agreements, Review Batch Docs, CoAs, Deviations, And Artwork. Ensure GMP Compliance, Traceability, And Regulatory Alignment. Support IPQA Checks, Sampling, Audits, And Real-Time Issue Resolution. Required Candidate profile Skilled in corporate QA documentation, third-party coordination, and artwork review Manage change control, audit readiness, and traceability Ensure regulatory compliance and product release approval

Role & responsibilities Execute daily production operations and ensure the efficient functioning of the department. Supervise and monitor manufacturing processes to ensure compliance with quality standards. Review and maintain production-related QMS elements, including Change Control, Deviation, Event Investigation, and Corrective and Preventive Actions (CAPA). Prepare and review Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Packing Records (BPRs). Address and resolve production issues promptly to minimize downtime and ensure continuous production. Respond to challenges or bottlenecks and implement mitigation strategies within defined timelines. Ensure that all processes and documentation comply with SOPs and protocols. Maintain and review all production-related records, including batch records, equipment logs, and production output reports. Prepare regular reports on production output, efficiency, and quality metrics for management review. Coordinate with the maintenance department to resolve equipment breakdowns and ensure smooth production activities. Oversee the document control system to ensure the availability and integrity of quality documents. Preferred candidate profile Bachelor's or Masters degree in Pharmacy, Life Sciences, Biotechnology, or a related field. Minimum of 1 year of experience in a production/QMS-related role within the pharmaceutical, biotechnology, or manufacturing industry. Strong understanding of QMS principles, regulatory compliance, and production processes. Ability to analyze and resolve production-related challenges effectively. Proficiency in documentation, report preparation, and adherence to SOPs.

Role & responsibilities Responsible for all in process Quality Assurance Activities Document issuance and control Preparation and review of SOPs, Protocols, Reports, BMR, BPR and QC Specifications Issuance and review of BMR and BPR and other quality system documents Internal audit and its compliance related activity Ensuring compliance to cGMP Prepare Annual Training Plan in co-ordination with Head of QA Schedule and coordinate the cGMP training session Assist in the delivery of new employee orientation training Assure training records are maintained for regular, temporary and contractors/consultants Check monthly log book and calibration of IPQA instrument and balance Stability and control sample management Preferred candidate profile Should be worked in QA Department Well versed with computers, MS officer knowledge is must. documentation skills required

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Role & responsibilities To take plant round and monitor production activities at shop floor. To prepare appropriate Quality related documents like SOP, BMR, BCR, BPR etc. To review BMRs, BCRs, and analysis records before release of API. To perform sampling of APIs and maintain its records. To maintain control samples of API and its records. To perform and ensure the cleaning of sampling tools. To provide line clearance at the time of product changes over. To review dispatch of finished product and maintain record for the same. To Investigate the deviations identified in co-ordination with QA-Head/Designee. Product quality review of API Process and cleaning validation monitoring in plant Preferred candidate profile Minimum 4 to 9 years of experience required Perks and benefits Best in the Industry

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

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety & quality standards. Work closely with manufacturing, R&D, and QC teams. Requirement: 2+ years of QA experience, preferably in cosmetics or pharma manufacturing. Required Candidate profile Skincare manufacturing & QC expertise Knowledge of FDA, GMP, ISO regulations Attention to detail & procedural compliance Strong analytical, problem-solving & com skills Ability to work with GMP proces

Job Title: Quality Assurance Manager Location: Rabale, Navi Mumbai Experience: 10 15 years Department: Quality Assurance Employment Type: Full-time Reports To: Quality Head About Fusion Scientific Laboratories Fusion Scientific Laboratories is a USFDA and EMA accredited pharmaceutical laboratory based in Rabale, Navi Mumbai , offering world-class services in Formulation Development , Analytical Solutions , and Integrated Pharmaceutical Services (CDMO) . We partner with pharmaceutical companies globally to deliver compliant and innovative solutions across the drug development lifecycle. Position Overview We are looking for a highly experienced Quality Assurance Manager to lead quality oversight for oncology product development, formulation, and pilot manufacturing , with a strong focus on compliance in both production and Quality Control (QC) Laboratory environments. The ideal candidate will have in-depth knowledge of GMP, regulatory compliance , and oncology product handling , with proven experience supporting regulatory inspections and audit readiness . Key Responsibilities General Quality Assurance Responsibilities Ensure end-to-end GMP compliance across formulation development, pilot manufacturing, and quality control functions for oncology products. Review and approval of Batch Manufacturing Records (BMRs) , analytical reports, and validation protocols for oncology drug substances and products. Lead deviation investigations , OOS/OOT management , and CAPA implementation in a timely and compliant manner. Maintain and improve quality systems such as Change Control, Risk Assessment, Quality Metrics, and Audit Trails. Ensure effective training programs are in place for staff involved in oncology manufacturing and testing, including PPE use and containment protocols. Support and host regulatory audits and client inspections; ensure constant audit readiness . Implement and monitor Data Integrity (ALCOA+) practices across all functions. Quality Oversight of cGMP QC Laboratory Oversee and ensure compliance of the QC laboratory with current GMP and GLP requirements specific to oncology products. Verify compliance with analytical method SOPs , regulatory compendia (USP, EP, IP), and internal specifications. Support implementation of Good Documentation Practices (GDP) in laboratory notebooks, logbooks, and electronic systems. Monitor proper functioning, calibration , and preventive maintenance of all critical QC instruments (e.g., HPLC, GC, ICP-MS, LC-MS/MS, etc.). Ensure environmental monitoring (EM) and microbiological testing for sterile oncology products are performed and reviewed per SOP. Facilitate timely investigation and closure of laboratory incidents, deviations, and out-of-specification (OOS) results. Collaborate with the QC and Analytical Development teams to ensure smooth and compliant execution of: Method transfers Reference standard qualification Sample management and chain of custody Oversee the archiving and retention of QC documents and raw data in accordance with regulatory and company requirements. Required Qualifications & Experience Master’s degree in Pharmaceutical Sciences, Chemistry, or a related discipline . 10–15 years of progressive experience in Quality Assurance , with exposure to oncology formulations , pilot-scale manufacturing , and cGMP QC laboratories . In-depth knowledge of ICH guidelines , USFDA, EMA regulatory expectations, and WHO GMP . Prior experience supporting regulatory inspections and/or client audits in a CDMO or oncology manufacturing setup. Strong understanding of HPAPI containment protocols , analytical method validation , and data integrity controls . Key Competencies Expertise in oncology product QA , QC laboratory compliance , and GMP system management Strong leadership and cross-functional collaboration skills Sound decision-making and risk assessment capabilities Proficiency in regulatory documentation and audit management Detail-oriented with a strong sense of ownership and accountability Why Join Fusion Scientific Laboratories? Be part of a growing, USFDA and EMA-accredited pharmaceutical laboratory focused on oncology innovation . Collaborate with top-tier pharmaceutical clients across the globe in a CDMO environment . Access cutting-edge technologies, a strong quality culture, and opportunities for professional advancement. Competitive salary, supportive leadership, and a high-performance work environment.

The ideal candidate will ensure that all products meet industry standards and comply with regulatory requirements Develop and maintain procedures to comply with external regulations (ISO, GMP, FDA) Lead audits and inspections for regulatory bodies Required Candidate profile Knowledge about ICH, USFDA, WHO , PMDA Japan, EDQM, guidelines. Technical knowledge on data review for FG, BMR, Stability Data, RM, Method validation Change control, CAPA, Incidents, OOS, OOT.

Ensure compliance with GMP & regulatory standards, oversee quality systems, audits & validations, manage QA team, review batch records, handle deviations/CAPA, support regulatory inspections, ensure product quality & safety across manufacturing.

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data. It will be essential for you to coordinate effectively with manufacturing units to ensure that products and processes align with regulatory requirements. Additionally, staying informed about the evolving USFDA regulations will be crucial, enabling you to provide impact assessments and strategic guidance to the organization. To excel in this role, you should possess a minimum of 7-10 years of hands-on experience in Regulatory Affairs CMC, with a specific focus on USFDA filings, particularly ANDAs. A strong understanding of ICH guidelines, USFDA regulations, and the regulatory frameworks applicable to generic drug products will be required. You should also have experience in preparing and reviewing technical documents in Module 2 & 3 (CTD format) and exposure to quality systems, BMR review, and interaction with production/plant teams. Your ability to manage the end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA, will be critical to your success in this role.,

The position of Officer in the Production Department at German Remedies Pharmaceuticals Pvt Ltd.(Sanand) is currently open for applications. As an Officer, you will report directly to the Production Head and be responsible for critical tasks within the department. Key Responsibilities: - Handling the Filling Area to ensure smooth operations - Managing the Washing and Autoclave Area for equipment sterilization - Reviewing and documenting Batch Manufacturing Records (BMR) - Preparing Standard Operating Procedures (SOPs) for various processes - Conducting Dispensing Activities as needed Requirements: - Qualifications: Bachelor of Pharmacy (B. Pharma) - Total Experience: 2 to 4 years in the pharmaceutical industry - Minimum of one year of experience at Zydus - Department Eligibility: Production This role is a Level 1 Neev position and is a replacement hire. If you meet the qualifications and have the required experience, please send your CV to Prabhaker.Tiwari@zyduslife.com to be considered for this opportunity.,

Walk-in Drive @ Hyderabad on 3rd Aug 2025 (Sunday) Strides Pharma is hosting a Walk-In Drive for multiple roles. Venue: Hotel Ravila Grand, Plot No 9, Mumbai Highway Road, Opposite Pranaam Hospital Lane, Sri Durga Colony, Madeenaguda, Hyderabad, Telangana 500049 Open Positions Department: Production (OSD) Experience: 2-5 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: Granulation, Compression, Coating, Capsule Filling, OSD Production, BMR, Production QMS, Change Control, Deviation, CAPA. Department: Packing (OSD) Experience: 2-5 years Qualification: B.Pharm/M.Pharm Job Location: Bangalore Key Skills: OSD Packing, Bottle Packing, Blister Packing, BQS, CVC, BPR Department: Quality Control Experience: 2-5 years Qualification: B.Pharm/M.Pharm/M.Sc. Job Location: Pondicherry Key Skills: HPLC, GC, UV, IR, KF, FTIR, Dissolution, LIMS, GLP Department: Quality Assurance-IPQA (OSD) Experience: 2-5 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: IPQA, BMR Review, BPR Review, Line Clearance, In process & process validation sampling. Department: Formulation & Development (OSD) Experience: 2-7 years Qualification: M.Pharm Job Location: Bangalore Key Skills: Planning & Execution of Lab scale experiments. DOE, Quality by Design, Product Development, Stability Protocol, Regulatory Market. Best Regards, Talent Acquisition Team, STRIDES PHARMA SCIENCE LTD

Role & responsibilities Education: B. Pharma/M.Sc./B.Sc. Experience: Min. 2 years Work profile: Shop floor IPQC (Tablet, Syrup, cream etc.) Basic knowledge of QA activities (Quality management system) Preferred candidate profile Email CV- Shubhamupadhyay.sanat@schwabeindia.com Phone -9628926944

Should have the experience in activities like QMS Activity, BMR Review, Change Control, Document Issuance, Vendor Qualification, Process Validation etc. Process validation / equipment Qualification protocol preparation and review Required Candidate profile Vendor qualification and validation

Overall handling of Quality Procedures & Quality Management System (QMS). Handling & Issuance of NCs, CAPA and Change Control. ISO Audits, PDI, BMR, Audit Documentation, Customer Audits Required Candidate profile BE/ Btech/ Diploma- Mechanical Engineering, Min. 1 year exp as Quality Executive/ Engineer in Medical Devices or Automotive Industry. Prior exp of handling Quality Procedures & QMS, CAPA, Audits.

Responsibilities: * Ensure compliance with GMP, GLP & BPR review. * Conduct process validation, cleaning verification & change control. * Collaborate on batch manufacturing & release processes. * Prepare SOPs, BMRs & BPRs.

Walk In Drive For Production Injectables In Formulation Division @ RK Puram Department:- Production Injectables Qualification :- B Tech | B Sc | B Pharmacy | M Sc | M Pharmacy Experience :- 2-4 Years Skills :- Documentation :- BMR & Process validation protocol document preparation & Review | SOP Preparation & Review | QMS Elements | Production & Audit Compliance Qualification :- ITI | Diploma Experience :- 2-4 Years Skills :-Filling Operator Qualification :- ITI | Diploma | B Sc |B Tech Experience :- 10-12 Years Skills :- Senior Filling Operators :- ALUS | Vial filling | Stoppering | Sealing Machine | PFS Division :- Formulation Interview Date:19-07-2025 (Saturday) Interview Time :- 9.00AM TO 2.00PM Work Location:- Unit-V, RK Puram Venue Location :- MSNF Unit-V, Rk Puram 25GX+XHX, Solipur, Telangana 509216 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Job Requirements: 1. Operators & Officers for OSD Production & Packing (Onco & Non-Onco) Experience: 0 to 6 Years Qualifications: I.T.I / Diploma / D. Pharmacy / B. Pharmacy Key Responsibilities: Operate equipment such as Granulation, Compression, Coating, Capsule Filling, Blister Packing, and Bottle Packing. Supervise production lines including Granulation, Compression, Coating, and Packing (Blister/Bottle). Good verbal and written English communication skills 2. Training Coordinator for OSD & Sterile Production & Packing Experience: Minimum 3 to 5 Years Qualification: B. Pharmacy Key Responsibilities: Conduct SOP training sessions for staff employees, casuals, and workmen. Ensure effective delivery of training on the shop floor. Maintain training records. Good verbal and written communication skills. Date: Saturday, 19th July 2025 Time: 9:00 AM to 2:00 PM Venue: Natco House, Road No. 2, Banjara Hills, Hyderabad 500034 (Opposite A.P. Productivity Council) Important Notes: Only candidates with formulation experience and regulatory exposure will be considered. Candidates interested in working at the Kothur location are requested to attend the interview. Encourage only male candidates due to rotational shifts, as it is in production areas.

Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate with external quality assurance officers during on-site inspections. Efficiently ensure that all the legal standards are met with great care. Provide assistance during the recruiting process. Efficiently create reports for tracking progress.Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

Roles and Responsibilities Maintain accurate records of all quality-related activities and reports. Conduct quality audits, internal audits, BMR review, capa, change control, GMP compliance, deviation management. Ensure adherence to cGMP guidelines during production runs. Identify areas for improvement through continuous monitoring of processes and implement corrective actions. Collaborate with cross-functional teams to resolve quality issues and improve overall productivity. Document issuance (i.e., Batch Manufacturing Record , Lab Note Book, Log books, analytical work sheets, SOP formats etc.,) Review of executed documents (e.g., Batch Manufacturing Record, analytical work sheets Equipments usage log books, area cleaning records, calibration records, preventive maintenance records, Lab Note Book,) Retrieval and archival of quality management system related documents. Preparation of annual schedules (GMP training schedule and On Job Trainings, Preventive Maintenance, Equipment calibration, Internal Audit and Management Review Meeting) and conducting according to these schedules. Initiate the change control, deviation related to quality functions. Preparation of Certificate of analysis Coordinating with External Testing Laboratories. Reviewing the completed analytical reports, Calibration reports for its compliance. Reviewing the Instrument/Equipment master Calibration schedules for its compliance. Assistance for the new analytical method development and validation as per the guidelines.

BMR Review, BPR Review, Line Clearance, Change Control, Deviation.

Job Responsibilities Sr. Executive Quality Assurance Headquarter: New Delhi/Faridabad Purpose of the Position :- To ensure document & data control activities are performed as per approved QMS. Job Responsibilities: 1. Responsible for document and data control activities related to QMS. 2. Responsible to do issuance of all prepared documents and retrieve all superseded documents. 3. Responsible to update all master document list as per requirement. 4. Responsible to update document tracking system. 5. Responsible to maintain all QA logbooks. 6. Responsible to do timely issuance of controlled logbooks, formats and other required documents to all departments as per requirement. 7. Responsible to maintain record of external origin documents. 8. Responsible to develop new product artwork as per requirement. 9. Responsible to revise existing product artwork as per requirement. 10. Responsible to maintain records of artwork and shade cards. 11. Responsible to review online filled BMR, BPR and all other batch related records. 12. Responsible to prepare & review MFRs of Raw material, In-process Material and Finished Products. 13. Responsible to prepare & review SOPs of QMS Processes. 14. Responsible to prepare & review APQRs. 15. Responsible to review documents related to OOS, Non Conformity, Deviation, CAR & Change control. 16. Responsible to prepare Quality Manual, Validation Master Plan and Site Master File. 17. Functional Reporting shall be as per departmental organogram. 18. Any other task assigned by the Reporting Manager. The responsibilities may be reviewed/added as per company requirements from time to time.

Responsibilities: * Lead QMS implementation & compliance * Ensure product quality through data review & annual product quality reviews * Conduct BMRRs, batch releases & equipment qualifications Office cab/shuttle Provident fund