138 Bpr Review Jobs - Page 2

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 assessment report and any other document as per requirement 11.Timely review of Batch Process & Control Records, Validation protocol / reports, Calibration, Qualification protocol / reports & Trend analysis data 12.Timely review of executed batch records and associated data 13.Keep vigilance on production operations 14.Review of Analytical Reports as per requirements 15.Participation in Audits & Compliance activity 16.In addition of above, any other responsibility assigned by Superior / HOD 17.Final release of critical intermediate and drug substance batches in LIMS and SAP 18.Risk assessment preparation and review 19.Draft MFR/BPCR/BPR review Qualification Required B. Pharm / M. Pharm Relevant skills / Industry experience 2-10 Years with Injectables or Biotech Induastry in IPQA department

Job Description Required for IPQA acitities. Required for Batch manufacturing record review. Required for line clearnace and other shop floor related activity of QA. Work Experience 3 to 8 years. Education Graduation in Pharmacy Competencies

SKS Enterpprises is looking for Portfolio Review Analyst to join our dynamic team and embark on a rewarding career journey Analyst plays a crucial role in driving data-driven decision-making processes within the organization This position involves analyzing complex data sets, generating actionable insights, and providing strategic recommendations to support key business initiatives Key Responsibilities:Data Analysis:Conduct in-depth analysis of large and complex datasets to extract meaningful insights Utilize statistical and data visualization tools to present findings in a clear and concise manner Strategic Planning:Collaborate with cross-functional teams to understand business objectives and provide analytical support for strategic initiatives Develop and maintain models to support forecasting, budgeting, and other planning processes Reporting and Dashboards:Design and create comprehensive reports and dashboards to track key performance indicators (KPIs) and metrics Automate reporting processes to improve efficiency and accuracy Trend Analysis:Identify trends and patterns in data to help anticipate opportunities and challenges Provide insights on market trends, competitor analysis, and industry benchmarks Decision Support:Assist senior management in making informed decisions by providing data-driven recommendations Evaluate the impact of proposed strategies on business outcomes Process Improvement:Identify areas for process improvement and efficiency gains based on data analysis Collaborate with teams to implement changes and measure the impact

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

To coordinate for the commissioning of all the equipment’s at different area of production and completion of all documents such as DQ /IQ/OQ/PQ before the commencement of the regular production. Required Candidate profile To ensure that the total shift operation in Production Department starting from Dispensing to Packing is done with adherence to cGMP.

Job Title:- KMIL- Wholesale Banking- Risk Monitoring Analyst Grade:- M4/M5 Location:- Mumbai Track financial and project performance covenant: Monitoring financial and project performance against predefined convenants. Identify deviations and promptly communicate findings to relevant stakeholders. Project performance analysis: Conduct through analysis of project performance metrics. Provide insights and recommendations to mitigate risks. Track Compliances to sanctions conditions: Moniotor compliance with sanctions conditions imposed on credit facilities. Take proactive measures to address any non- compliance issue Site Visit: Conduct on site visit to assess the progress and status of projects. Documents observations and report findings to management Compliance with RERA regulations: Ensure adherence to regulatory guidelines and internal policies. Stay updated on regulatory changes and implement necessary adjustments. Early warning signal tracking: Identify early warning signal as per the existing policy indicating potential credit risks. Collaborate with relevant teams to develop strategies for risk mitigation. Coordination with business and credit underwriting team Liaise with business units and credit underwriting teams to gather relevant data and insights. Collaborate on credit risk assessment and monitoring activities. Job Requirement- MBA with 5 to 8 Years of experience is preferred

Enhance images by correcting resolution and composition, cropping images and adjusting tone, color, saturation and brightness. Adding or removing objects from an image or inserting text. Smoothen skin, remove big creases, general tidy up, clean up floor, sharpen clothing better where it looks too big, remove flyaway/loose hair strands Have an eye for art and composition as they relate to whats typically desirable in a photographic image. To present your designs and ideas when required to all levels up to and including managers & clients. To constantly review competitor sites and make recommendations to maintain client s position as market leader, ensure client s on-line content continues to exceed customer expectations in terms of performance and presentation The combination of an artistic eye and technical training in photograph editing is necessary

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

You will be responsible for ensuring line clearance at the start-up of the tablet section, including compression, coating, and capsule filling sections. Additionally, you will be in charge of maintaining logbooks for the Tablet section, manufacturing area, and grinding section. In-process sampling of tablets and final sampling of tablets will also fall under your responsibilities. You will be tasked with conducting online reviews of Batch Production Records (BPR) for Tablet, Capsule, and Jawkut sections. Monitoring the environmental conditions in the respective operational areas will be crucial. Issuing tablet excipients and empty capsules, as well as checking the online parameters of Tablets and Capsules, will be part of your daily routine. This is a full-time, permanent role with benefits such as internet reimbursement, leave encashment, and paid sick time. The work schedule will be in the morning shift. A background in pharmaceuticals or herbal medicine is preferred. A Bachelor's degree is also preferred. The work location will be in person.,

Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors. 4. Preparation & review of quality risk assessment reports of products & general systems 5. Conduct on the Job Training and cGMP trainings. 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records. 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification. 8. Co-ordination with the customer for compliance and day to day issues. 9. Quality agreements review and preparation. Job Qualification: Masters in Chemistry (Any specialization) Job Experience: 10 to 12 years Desired attributes: Technical / Functional: Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance). Should have sound command on the English with speaking and Writing. Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions. Behavioral: Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

Role & responsibilities Production chemist and QC chemist Preferred candidate profile HPLC,GC wet lab,BPR,BATCH PLAN,REACTORS,ANALYSIS,WET LAB,INSTRUMENTATION, Perks and benefits As per company norms

KPMG India is looking for Executive - Adobe QA to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

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

You will be responsible for ensuring line clearance for the start-up of the tablet section including compression, coating, and capsule filling areas. Additionally, you will be in charge of accurately filling logbooks for the Tablet section, manufacturing area, and grinding section. Your duties will also include conducting in-process sampling of tablets and final sampling, as well as carrying out online reviews of Batch Production Records (BPR) for Tablet, Capsule, and Jawkut sections. Monitoring environmental conditions in the respective operational areas will be another key aspect of your role. Issuing tablet excipients and empty capsules and checking online parameters of Tablet and Capsule will also be part of your responsibilities. This is a full-time, permanent position with benefits such as internet reimbursement, leave encashment, and paid sick time. The work schedule will be during the morning shift. A background in pharmaceuticals or herbal medicine is preferred, and a Bachelor's degree is preferred for this role. The work location will be in person.,

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

Roles and Responsibilities Prepare batch manufacturing documents, including BMRs, BPRs, and BPR reviews. Ensure compliance with GMP guidelines during API production. Conduct OOS investigations and implement corrective actions as needed. Collaborate with cross-functional teams to resolve documentation-related issues. Maintain accurate records of all documentation activities. Desired Candidate Profile 3-6 years of experience in API production or related field (document preparation). Strong understanding of GMP compliance and regulations. Proficiency in document preparation software such as BPR review tools. Experience with investigation procedures for OOS events.

1.Perform and monitor In-process Quality Assurance activities during the manufacturing process. 2.Responsible to perform line clearance activities in different stages of manufacturing and Monitoring of cleanroom behavior, aseptic activities. 3.Responsible to verify the In-process samples for quality testing and ensure the test results of products at various stages of manufacturing. 4.Review and verify documentation related to manufacturing processes i.e., BMR, BPR and GMP documents, ensuring accuracy and completeness. 5.Regularly inspect and assess manufacturing operations to ensure compliance with quality standards and procedures. 6.Responsible to Preparation Review of standard operating procedures. 7.Responsible to ensure cGMP and GDP during document preparation and review. 8.Ensure that all in-process activities align with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). 9.Responsible to review of Plasma inward, sampling procedures, Issuance and Reconciliation. 10.Responsible to Review and compliance of Down stream activities and Filling activities as per established procedures. 11.Responsible to involve in Change controls, Deviations, CAPA and other QMS activities. 12.To get involved in Process validation, cleaning validation and APQR activities. 13.To Involve in Risk assessment procedures with the coordination of SMEs. 14.Responsible to perform additional activities assigned by the superiors/ Head of the department.

1.To involve in plasma products manufacturing. 2.Follow shift and production schedules. 3.To complete the assigned trainings timely. 4.To Monitor the differential pressure, temperature and humidity of the classified area. 5.To Ensure the area, equipments cleaning and readiness of equipments for batch activity. 6.Preparation of buffers and other solutions for downstream process. 7.Handling of process related instruments and equipments in downstream process (DSP). 8.Perform all the assigned manufacturing activities as per the defined procedures (SOP, BMR, Protocols) and record the details in respective document. 9.Checking the availability of stock of chemicals, solvents, raw material etc. 10.Coordinate with cross functional teams for smooth batch operations. 11.To maintain the facility to compliance with GMP. 12.Responsible for execution of relevant documents as per GDP. 13.To involve in equipment qualification and validation of the downstream equipments. 14.To involve in execution of process validation batches and regular manufacturing batches. 15.Provide samples to QC and take follow up for QC testing result. 16.In case of any abnormalities/ deviation observed should be recorded and informed to process in-charge to avoid any quality issues in the product. 17.To ensure adherence to safety procedure and report unsafe conditions and incidents to Supervisor.

1. Follow shift schedule and production schedule as per process requirement. 2.Handling of plasma collection, sanitization, washing, cutting, pooling and thawing. 3.Handling of plasma fractionation process steps. 4.Compliance to all approved procedure, documents and GMP activities. 5.Performing all the assigned manufacturing activities in confirmation to BMR, protocols and recording the details in record sheets and logbooks. 6.In process samples sending to QC for analysis. 7.Performing COP, CIP, PHT and SIP of all the process vessels and equipment. 8.Performing calibration of pH, conductivity meters, turbidity meter, weighing balances and other equipment. 9.Preparation of buffers and other solutions for plasma fractionation process. 10.Monitoring of area cleaning, equipment surface sanitization, differential pressure, temperature and humidity 11.Monitoring and recording the temperature of freezer room and cold room. 12.To get involved in trouble shooting and managing day to day activities. 13.Checking the availability of stock of chemicals, solvents, raw material etc. 14.Report unsafe conditions and incidents to shift in-charge. 15.Adherence to safety procedures. 16.Awareness on PPE usage.

1. To perform the equipment sanitization and cleaning. 2. To perform and ensure area cleaning and sanitizationactivities. 3. To prepare and filter disinfectant solutions. 4. To perform the CIP, PHT and SIP of the process vessels. 5. To operate the machines and equipments like autoclave,lyophilizer, vial washing, vial filling and vial capping machine, vialpasteurizer and manufacturing vessels. 6. To perform the vial washing, filling and sealing machinechange parts assembling and dismantling according to different vial sizes. 7. To perform activities like machine parts cleaning, loadpreparation, load wrapping and garments washing. 8. Adhere to cGMP practices during batch processing andoperation of equipment and GDP practices. 9. All the GMP documents e.g., BMR and logbooks to be filledon time and revise periodically. 10. Adhere to aseptic batch processing and gowning practicesduring performing aseptic activities in DPM area. 11. To plan and ensure availability of machine and material asper the batch requirement. 12. To participate in Media fill, Trial batch and Validationbatch activities. 13. To involve in batch execution. 14. To support the batch manufacturing activities. 15. To perform and coordinate in site acceptance test,Installation qualification, Operational qualification and Performance qualificationsfor new equipments. 16. To maintain the Inventory consumable required for dailyactivities. 17. To coordinate with other cross functional team for smoothfunctioning of departmental activitie s.

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for operation and handling of Dataloggers, HVAC related equipments. 5. Responsible for compilation and review of validation raw data and test certificates. 6. Responsible for preparation of Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ), revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling of risk assessments, deviation, change control and incidents related to qualification/validation. 11. Responsible for preparation of Utilities Annual summary reports.

1. To perform Equipment operation and cleaning. 2. To supervise the Visual inspection and batch packing execution as per plan. 3. To perform the documentation as per Batch record and SOP. 4. To perform the equipment qualification as per protocols and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Co-ordinate to cross functional team as per day-to-day activities. 7. Responsible for SOP, MPR and BPR preparation and revision. 8. Co-ordination with team to execute daily packing and visual inspection plan. 9. Ensure the training completion before doing activity. 10. To raise batch record request as per plan. 11. Responsible for QMS related activity(Change control, Deviations, Batch record) in packing and visual inspection activity. 12. Monitor day to day activities. 13. Reporting all the activities, incidents and problems to Reporting officer

1. Follow SOPs, GMP and safety practices. 2. Facility Area cleaning, Equipment cleaning, drains cleaning sanitization. 70 % IPA arrangement. Discarding general waste, rejects and biowaste. Log books updation. Spillage management. Updating of BMRs and annexures online. 3. Material Arrangement of plastic / glassware. Material packing for sterilization. Arrangement of garments. Arrangement of materials. 4. Process Arrangement of drums and installation of bags. Collection of WFI. Movement of prepared media/buffer to process rooms. Assisting in cleaning of equipments. Movement of samples. Execution of production activities. Monitoring of batch parameters. Arrangement of HDPE Drums, Vessels and installation of SUM bags and liner bags. Samples handling (Sampling and labelling). Handling of Depth filters assembly and harvest activities. Media Buffer preparation activities for process. LN2 container handling for filling activities. 5. Participate in training programs as per training schedule. 6. Responsible for operation of following production equipments (but not limited to): Mixing systems Weighing balance Magnetic stirrer Peristaltic pumps pH meter Cold Room Freezer Heat exchanger Depth filter holders Laminar air flow cabinet Biosafety cabinet Pass box LN2 container

Responsible for production activities Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room Training: Attending training on SOP's / GMP as per schedule.