50 Bmr Review Jobs - Page 2

Responsibilities: * Conduct BPR reviews, BMR reviews, process validation & cleaning validations. * Ensure compliance with industry standards during equipment & water validations. Accidental insurance Annual bonus Leave encashment Gratuity Provident fund

Walk-in @ GOA We are hiring multiple positions for our manufacturing facility at AHMEDABAD as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / Market Compliance / IPQA - (injectables) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY CONTROL (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M.Sc. (Organic Chemistry / Analytical Chemistry) B. Pharmacy / M Pharmacy MICROBIOLOGY (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M. Sc (Microbiology) Injectable Manufacturing (Executive/Senior Officer / Officer / Associate) Experience - 01 to 06 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations/ Visual inspection / QMS activities OSD Manufacturing (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing and Packing operations / QMS activities Time and Venue : 06th July 2025, 09:30 Hrs to 17:00 Hrs ______________________________________________________ The Fern Kesarval Hotel, Verna Plateau GOA -403710 _____________________________________________________ We would be very happy if you forward or refer any of your colleagues matching the requirement. *Having relevant qualification and experience only can attend the scheduled walk-in.

Planning & Co-ordinate Internal/ External/Customers Audits. Reviewing Customer audits and non-conformity reports and ensuring corrective actions are effectively implemented. Validation protocols and reports. Reviewing BMR, Analytical Records.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

Role & responsibilities J ob Summary We are seeking an individual for the Quality Assurance team, responsible for ensuring line clearance, material verification, and conducting in-process checks according to batch manufacturing and packing records. The role includes timely sampling/testing, coordination in cleaning validation, and ensuring compliance with technology transfer and exhibit batches, including the review and certification of batch records. Roles & Responsibilities • You will be responsible for performing line clearance, material verification, start-up checks and in-process checks as per the batch manufacturing record, and batch packing record. • You will be responsible for the timely sampling/testing of In-process, reserve, and finished samples and stability samples/environmental monitoring. • You will be responsible for coordination in cleaning validation, performing sampling and compliance. • You will implement and comply with Technology Transfer and initiation of exhibit batches. • You will review batch manufacturing and batch packing records and certification of the same after execution. educational qualification: A Bachelors degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 4 to 7 years of experience in pharmaceutical manufacturing or a similar role Technical Skills • Knowledge of microbiology and aseptic practices, cleaning validation activities, sampling and relevant standards. • Proficiency in performing line clearance, material verification, start-up checks, and in-process checks following batch manufacturing and packing records. • Experience in timely sampling and testing of in-process, reserve, and finished samples, as well as stability samples and environmental monitoring. • Skilled in reviewing batch manufacturing and batch packing records, ensuring accuracy and certification after execution. Behavioral Skills • Attention to detail in performing line clearance, verification, and record reviews. • Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities. • Communicates effectively with team members and stakeholders regarding batch-related activities and compliance. • Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification. • Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.

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 API’s 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 8 to 13 years of experience required Perks and benefits Best in the Industry

Urgent requirement For Production Injectables In Formulation Division - Kothur & RK Puram Department:- Production Injectables Qualification :-ITI | BA | Diploma | B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Skills :- Operators :- Filling | Aseptic | PFS | VIAL | OPHTHALMIC Filling machine | Bottle sealing or Capping | Product & Disinfectant filtration activities | log books & BMR recording | Filling machine PHT,CIP & SIP operations Division :- Formulation Work Location:- MSN Formulation Unit II, Kothur & MSN Formulations Unit- V, RK Puram 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.

Review of BMR and other production and quality control related documents. Major experience in API IPQA activities (like: Plant rounding & monitoring). Preparation of APQR.

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.

Walk In Drive For Production Injectables In Formulation Division @ Corporate Office Department:- Production Injectables Qualification :-ITI | BA | Diploma | B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Skills :- Operators:- Filling | Aseptic | PFS | VIAL | OPHTHALMIC Filling machine | Bottle sealing or Capping | Product & Disinfectant filtration activities | log books & BMR recording | Filling machine PHT,CIP & SIP operations Division :- Formulation Interview Date:- 15-06-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSN Formulation Unit II, Kothur & MSN Formulations Unit- V, RK Puram Venue Location:- MSN Corporate, H. No. 2-91/10 & 11 /MSN, Whitefield's, Kondapur, 500084 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Lyo, Compounding, Autoclave,Vial Filling, Vial Washing, Sealing,Aseptic Processing Area, Tunnels, Labelling, 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.

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

We are hiring production officer for our pharma intermediate manufacturing industry. Requirement:- Qualification:- ITI AOCP/B.Sc. Experience :- 2 to 4 year in pharma industry required Location:- Panoli Benefits:- P.F/Bonus

Job Profile : Manufacturing Chemist Location : Neermarna, Rajasthan Experience: Minimum 10 years of experience into same Pharmaceutical industry Salary : UP-to 7.5 Lpa ( Negotiable for good candidate ) Notice period : Immediate Role & responsibilities Develop and optimize pharmaceutical formulations. Over see and maintain consistent,high-quality production batches. Ensurecompliancewithregulatoryandqualitystandardsacrossmanufacturingprocesses. Preferred candidate profile Educational Qualification : B.Pharma/M.Pharma. Industry Experience: Minimum 10 years of relevant experience in the pharmaceutical formulation industry. Regulatory Approval: Must be approved in the manufacturing of Tablets,Capsules,Dry Syrups, Liquid Orals, and External Preparations in Beta-Lactam and Non-Beta-Lactam categories (or Non-Beta-Lactam only). Technical Expertise: In-depth knowledge of manufacturing a wide range of: Tablets :Uncoated,film-coated,sugar-coated,enteric-coated, dispersible,and sustained-release formulations. Liquid Orals : Syrups and suspensions. o Capsules&Dry Syrups. External Preparations :Creams,ointments,and tube-based formulations. Proficientinpreparing: MasterFormulationRecords(MFRs) BatchManufacturingRecords(BMRs) StandardOperatingProcedures(SOPs) ProcessValidationandCalibrationDocuments Strongunderstandingofpharmaceuticalmanufacturingsoftwareandgeneralcomputer applications. Interested can connect on 7217623080/hr.msservicesggn@gmail.com

Job Description 1 Master & Control of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records to concern departments. 2 Issuance of all documents like SOPs, BMR, Specification & MOA, logbooks ,calibration records to concern departments 3 Preparation of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records of concern departments 4 Reviewing of HPTLC, TLC, GC reports, peaks, graphs etc 5 Checking & signing of BMR of Liquid syrup, Tablets & Mother tincture section. 6 Receipt & storage of executed documents like BMR, Analytical logbooks, calibration records etc. 7 Receipt & storage of control samples of finished product, raw material etc. 8 Receipt, storage & destruction of superseded SOPs. 9 Preparation of process validation protocol & Report. 10 Receipt & storage of executed validation protocol & Report 11 Receipt & storage of executed Qualification documents of equipment & instruments 12 Stability studies documentation with help of Quality control. 13 Preparation & Revision of SOPs of Quality Assurance department. 14 Compliance and preparation of Audit Report. 15 Maintenance of control sample room & Documentation room. 16 Training of sub ordinates & evaluation. 17 Preparation of Training schedule and its implementation and monitoring. 18 Identification of training needs to internal/ external to the sub ordinates. 19 Compliance of Audit Report from Government authorities (FDA). 20 Any other activity assigned by the management.

A. Job Objective Monitor and review In Process quality control checks to meet the required quality compliance as per specifications. Strategic and planning Functional Core:- Review and provide decision based on the IQC sheet Online feedback to production for correction Daily plant round for ensuring compliance of SOPs, GDP, GMP guidelines etc. on the shop floor Refer ZMIC for special instruction during color change/ product change and guide the IQC operator for the same. Review the implementation of the same. Monitoring CAPA during shifts. Investigation of internal stranger/failure to identify the Root cause analysis and take corrective/preventive action for the same. Track instance of repeat failure from operators and take measures/set processes to avoid re-occurrence of the same and to ensure FTR. Line clearance of camera inspections, HCM, ATS, printing machines and Final Inspection System Ensuring document verification generated during shift on daily basis against defined standards Internal process Preparation of various reports Maintenance and verification of gauges to ensure proper calibration of these equipments on a regular basis in each shift Ensure verification of shade against master and Macbeth report Verification of daily profiles and online graphs Periodically conduct process, product and systems Audit. To provide data for annual product quality review & Participate in APQR and finalise the recommender's People development Ensure proper manning and shift handling, shift activities. Effective training to the operators with evaluation for compliance. Effective manning to utilization of available sources.

Desired Candidate Profile 2-5 years of experience in Quality Assurance & Compliance role in API manufacturing industry. MS/M.Sc(Science) degree in Chemistry Strong understanding of GMP & Regulatory Compliance, Document Control & SOP Management, APQR, CAPA & Market Complaint Management.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

Job Overview The incumbent will be responsible to ensure that all external and internal processes and systems are followed before our product reaches our customers. You will be responsible for inspecting procedures and outputs and identifying mistakes or non-conformity issues. Qualification: B. Sc. / B. Pharm + M. Sc. /M. Pharm Experience: • 8 to 12 years in Quality Assurance • Thorough knowledge of methodologies of quality assurance and standards • Maintaining cGMP quality standards, ensuring stringent adherence to quality standards, norms & practices, identifying gaps & taking corrective actions. • Excellent numerical, communication skills and understanding of data analysis/statistical methods • Attention to details and Stake Holder management Roles & Responsibilities Process Documentation & Review • Ensure and review adherence to the processes and product quality through site documentation review -BMR/BPR -APQR -Monthly reports -IPQC data -Stability data - Validation Protocol/ Report • Preparing QA SOPs as applicable for TP sites and PEL CPD business and their effective implementation • To design, implement and ensure adherence to Quality Technical Agreement at Third Party Level • Review of Specifications and STPs applicable for Contract manufacturing sites. • Batch release, Ensuring timely analysis of batches and quality of products. • Review of Change control and Deviation at TP sites. • Handling Market complaints and carry out investigation and review, to find out the root cause for the complaint. • Handling of OOS results at contract manufacturing sites and carry out investigation to find out the root cause for the OOS observed. • Departmental SOPs preparation, implementation and Training of SOPs at Head Office. • Review of Specifications and STPs applicable for Contract manufacturing sites. • Review of Annual Product Quality Review of contract manufacturing products and improvement based on the identified Gaps. Process, System and Product Maintenance & Upgradation • Experience in quality standards and regulatory compliance: Implementation of quality system inline with current regulatory requirements. Ability to handle strategic planning by ensuring CMO governance, Gap analysis and risk mitigation documentation, product quality complaints investigation and recall handling. • Ensures Corrective and Preventive Actions (CAPAs) are implemented by CMOs and every task is performed in accordance with established SOPs • Training need identification and imparting Trainings at Contract manufacturing sites. • To upgrade quality system by ensuring tracking systems to monitor timelines and effective compliance to planned system. • Experience in Handling Technology Transfer (Analytical/ Process): Facilitate in transferring registration and relevant Quality document to CMO & ensure proper documentation of the transfer as per quality requirements

Role & responsibilities Checking of SOP Compliance. Preparation and Updation of the Site Master File . Preparation and Updation of Validation Master Plan QA SOPs preparation/Revision. Execution of product Disposition/dispatch activity. Tracking of SOP revision due of all departments. Issuance, retrieval and destruction of SOP controlled copies. BMR, BCR issuance, retrieval and review. Line clearance after change over in production areas. Monitoring of routine manufacturing activities. Handling of Change Control. Handling of Deviations. Assist HOD QA for any technical information needed, documents requirement so as to carryout smooth and consistent day-to-day QA activities. Filling customer questionnaire. Feedback giving to marketing related queries. Participate in customer and regulatory audits. Performing vendor/supplier audits. Performing Internal audits. Review of validation & Qualification documents. Preparation of Annual Product Quality Report & updating online trend analysis. Vendor Qualification activity. PR requisition in oracle. Verifying batch no. correctness in oracle before issuance of batch manufacturing records. GMP rounds. Retained documents management. All documents issuance, retrieval and review. Label, Seals procurement, Issuance, Control and Inventory Management. Day-to-day Coordination with all departments. Controlled Copies Issuance related to all departments. Preferred candidate profile Post Graduate in M.Sc with 6 to 8 years or relevant industry experience. Should be able to handle independently. Thorough knowledge of SOP preparation, validation and audits.

Role & responsibilities Conduct in-process checks during various stages of sterile injectable manufacturing, including dispensing, compounding, filtration, filling, and sealing. Perform line clearance and area clearance before the start of manufacturing and packaging operations. Monitor aseptic practices and personnel hygiene compliance inside cleanrooms and controlled areas. Verify critical process parameters and environmental conditions during batch processing. Ensure compliance with SOPs, batch manufacturing records (BMR), and batch packaging records (BPR). Participate in visual inspection activities and oversee container-closure integrity checks. Monitor the usage and replacement of sterilized garments, materials, and equipment in aseptic areas. Raise deviations, non-conformances, and change controls as needed. Assist in investigations for OOS, OOT, or any batch-related quality issues. Provide training to operators and workers on GMP, GDP, and aseptic technique

Position : Section Head - Batch Release QA Functional Area: QA Reports to: QA Head Grade: G9B Department: Quality Location: Halol (OSD) POSITION SUMMARY Responsible for IPQA activity and strategy in line with Sun Pharma Compliance, Product Quality Management objectives and Regulatory requirements. Responsible for planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or Procedures. Identify and implement solution for improving existing site quality assurance systems and processes Involvement in co-ordination of activities for software like SAP HANA at plant Responsible for review and Approval of Quality management/GMP records. Responsible to ensure and perform site data review of batch records for completeness of documentation, approval and rejection of materials per current good manufacturing procedures and escalation of quality incidences, Continuous process verification (CPV). Manage the batch release function at site wrt documentation, systems, approval and rejection of materials, products at the Site per current Good Manufacturing Practices requirements. The incumbent will assure individual compliance with the all concerned regulatory requirements, GxPs and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures. Key responsibilities: 1. Ensure compliance to regulatory requirements on product, process, equipment and release procedures. 2. Manage Batch release activities for commercial dispatch. 3. Escalate compliance concern to concern stakeholder. 4. Review, compliance of BPR and batch release for commercial dispatch. 5. Review and approve the investigations, CAPA, and effectiveness checks with adherence to timeline. 6. Execute change control and risk assessment whenever required. 7. Ensure Quality Metrics, Quarterly BPR report as per specify timeline. 8. Ensure timely Batch release through electronic system. 9. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures. 10. Follow the EHS policy and maintain the compliance to GMP requirements. 11.Co-ordination with QPs and customers of different region for batch release. 12.Management of Technical agreement with QP and Customers. 13.Responsible for oversight in warehouse and BSR. 14.Management of retain sample storage , inspection and life cycle management. MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS M.sc / M. Pharm/ B. Pharm 15 years with work experience preferred. REQUIRED SUCCESS ATTRIBUTE Knowledge of GxPs, cGMP and other regulatory requirements. Planning and Prioritization Collaboration Accountability Compliance Customer Service orientation Secondary Success Attributes People Connect Attention to detail Emotional control Effective Communication & Problem solving WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Role & responsibilities We are looking for candidate on below criteria at our Nalagarh Plant Himachal Pradesh location. Candidate must have completed Pharma, M.Sc. or B.Sc. in Chemistry. Experience of regulatory industry would be preferred. Candidate should have 1-3 years of working experience Preferred candidate profile Responsible for Line clearance in Warehouse and Production area during dispensing, MFG, Filling and Packing & review of log books and status label of each equipments before start of activity. Responsible to carry out in-process checks as per respective Batch Production Record in Manufacturing, packing and warehouse. To ensure that the manufacturing and packing operations are carried out as per the instructions given in the Batch Production Record. Responsible for collection of in-process samples, FP sample, control samples, validation & stability samples. Responsible to make SAP entries, Release of inspection lot of SFG & FG, Physical sampling confirmation, Approval of Batch Production Records for printing and additional page issuance. Responsible for online review of Batch Production record and make entry of data required for trending in maintained excel sheet for preparation of APQR. Responsible for Line clearance in Warehouse and Production area during dispensing, MFG, Filling and Packing & review of log books and status label of each equipment’s before start of activity. Responsible to carry out in-process checks as per respective Batch Production Record in Manufacturing, packing and warehouse. To ensure that the manufacturing and packing operations are carried out as per the instructions given in the Batch Production Record. Responsible for collection of in-process samples, FP sample, control samples, validation & stability samples. Responsible to make SAP entries, Release of inspection lot of SFG & FG, Physical sampling confirmation, Approval of Batch Production Records for printing and additional page issuance. Responsible for online review of Batch Production record and make entry of data required for trending in maintained excel sheet for preparation of APQR. Perks and benefits

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety, and 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

Role & responsibilities 1. Preparation of Drug Master File for US, EU and Row countries according to year plan. 2. Preparation and submission of Annual Reports, Amendments and updates to filed DMFs. 3. Preparation and Submission of responses to queries from customer and regulatory authorities. 4. Preparation of Technical information package (TIP) based on customer requirement. 5. Adequacy review of documents required for Drug Master File & TIP preparation like BMR, process validation reports etc. 6. Coordination with R&D, Quality Control and Quality Assurance to collect required documents. 7. Evaluation of impact of changes to the submitted DMF’s. Preferred candidate profile Only API - Industry Experience candidate required.

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety, and 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