36 Bmr Review Jobs - Page 2

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etc. 7 Receipt & storage of control samples of finished product, raw material etc. 8 Receipt, storage & destruction of superseded SOPs. 9 Preparation of process validation protocol & Report. 10 Receipt & storage of executed validation protocol & Report 11 Receipt & storage of executed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