159 Bpr Jobs - Page 2

Job Title: Quality Assurance Officers (4 Positions) Company: Nourish Pharmaceutical Pvt Ltd Location: Kheda, Gujarat Job Type: Full-time Nourish Pharmaceutical Pvt Ltd is a leading pharmaceutical company committed to delivering high-quality products. We're expanding our Quality Assurance team and looking for talented professionals to join us. Positions: 1. Quality Assurance Officer - Production 2. Quality Assurance Officer - QMS 3. Quality Assurance Officer - Validation & Qualification 4. Quality Assurance Document Control Officer Job Descriptions: 1. Quality Assurance Officer - Production - Key Responsibilities: - Ensure cGMP compliance in production areas - Manage and review Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and Master Formula Records (MFRs) in Pharma Cloud - Conduct in-process quality checks and documentation - Verify dispensing activities and line clearance - Collaborate with production team to ensure quality and compliance - Core Skills: - Attention to detail and analytical skills - Strong knowledge of cGMP, SOPs, and quality control procedures - Excellent communication and interpersonal skills - Experience & Qualification: - 0-3 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in quality assurance or a related field is an added advantage 2. Quality Assurance Officer - QMS - Key Responsibilities: - Manage deviations, CAPAs, and document handling - Ensure compliance with Quality Management System (QMS) standards - Conduct internal audits and facilitate external audits - Review and update SOPs, policies, and procedures - Collaborate with departments to ensure quality and compliance - Core Skills: - Strong analytical and problem-solving skills - Excellent communication and interpersonal skills - Ability to work independently and prioritize tasks - Experience & Qualification: - 1-3 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in quality assurance or a related field is an added advantage 3. Quality Assurance Officer - Validation & Qualification - Key Responsibilities: - Plan, coordinate, and execute validation and qualification activities - Ensure compliance with validation and qualification protocols - Review and approve validation reports and documentation - Collaborate with departments to ensure quality and compliance - Identify and mitigate risks associated with validation and qualification - Core Skills: - Strong knowledge of validation and qualification procedures - Excellent analytical and problem-solving skills - Ability to work independently and prioritize tasks - Experience & Qualification: - 1-5 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in validation and qualification or a related field is an added advantage 4. Quality Assurance Document Control Officer - Key Responsibilities: - Manage and maintain document control system - Implement and maintain change control system - Issue and maintain logbooks and records - Ensure plant and product documentation is accurate and compliant - Collaborate with QA team to ensure document accuracy and compliance - Core Skills: - Attention to detail and organizational skills - Basic knowledge of cGMP and quality control procedures - Excellent communication and interpersonal skills - Experience & Qualification: - 0-2 years of experience in a similar role within the pharmaceutical industry - B.Pharm, B.Sc or M.Pharm degree in Pharmacy or a related field - Certification in validation and qualification or a related field is an added advantage - All positions open for Fresher B.Pharm or M.Pharm degree in Pharmacy, Willingness to learn and grow in a quality assurance role How to Apply: If you're a motivated and detail-oriented individual with a passion for quality assurance, please submit your resume to info@nourishpharma.com

Execute and monitor production activities as per SOPs and cGMP guidelines. Ensure compliance with safety, health, and environmental regulations during production operations. Handle day-to-day production activities for API and intermediate products. Required Candidate profile B.Sc. / M.Sc. (Chemistry) / B.E / B.Tech. (Chemical Engineering) with 2 to 7 years in API or Intermediates Manufacturing Strong knowledge of API / Intermediates manufacturing processes.

Hiring for Production Chemist Job Location - Jammu (Sambha) Interview Location - Chandigarh Salary bar - 5LPA - 5.5LPA Max Industry pref. - Pharma (API) Interested one share resume on meenakshikandpal@tdsjobs.com 9041666549

Key Responsibilities Execute daily production operations as per approved SOPs, BMR/BPR, and production plan. Handle manufacturing processes, equipment operations, cleaning, and changeover activities. Prepare, review, and maintain production documentation (BMR, BPR, logbooks, and SOPs). Ensure adherence to cGMP, GDP, and EHS standards across production processes. Actively participate in QMS activities deviations, CAPA, change controls, incident handling. Coordinate with QA, QC, Engineering, and Warehouse for smooth batch execution. Assist in audit preparation (internal, regulatory, and customer audits) with proper documentation. Monitor yield, productivity, and process improvements to minimize batch rejections. Ensure proper training and compliance of operators/technicians on SOPs and safety practices.

Hiring for Production Chemist Job Location - Jammu (Sambha) Interview Location - Chandigarh Salary bar - 5LPA - 5.5LPA Max Industry pref. - Pharma (API) Interested one share resume on meenakshikandpal@tdsjobs.com 9815675900

We are looking for an experienced Production Executive with strong expertise in Liquid Injection and Parenteral Manufacturing . The ideal candidate will independently manage sterile production operations, ensure compliance with quality standards, and drive efficient utilization of resources. Key Responsibilities Supervise and manage the manufacturing of Liquid Injections and Parenterals . Oversee and maintain the sterile filling area of liquid parenterals. Handle the Liquid Injection section independently . Supervise the washing section, autoclave, and tunnel operations . Manage batch preparation, filling, washing, visual inspection, and packing sections . Prepare Sterile Water for Injection (SWFI) using AFFS machine. Control production parameters, ensuring proper dispensing of materials with specific strength and grade. Ensure line clearance before initiating product formulation and machine setup. Execute daily production planning , effectively utilizing manpower and achieving planned output. Optimize usage of raw materials, packing materials, and manpower . Maintain BMR, BPR, log books, and other production-related documents concurrently with the process. Manage deviations in manufacturing processes and coordinate with Quality Assurance & Quality Control teams for smooth workflow. Requirements Education: B.Pharma / M.Pharma (Any Specialization). Experience: Minimum 5- 6 years in sterile/Liquid Injection/Parenteral production. Strong knowledge of GMP, documentation practices, and sterile operations . Excellent organizational, problem-solving, and team management skills. Benefits Competitive salary with performance-based bonuses . Comprehensive health, dental, and vision insurance . Retirement savings plan with company contribution. Professional development and career growth opportunities. Supportive and collaborative work environment.

Designation - Manager - Quality Assurance Company - Leading Pharma Raw Material Mfg. Company Job Location - Dahej, Bharuch Qualification - B.Sc. / M.Sc. / B.E.- Chemical / B.Pharm Experience - Min. 8yrs. and above share with your friends Required Candidate profile company will provide transportation facility from Bharuch. Responsible for handling QA / GMP Related documentation QMS, Audit Preparation, Vendor Questionnaire, Market Compliant & Customer Compliance

Develop SOPs for production, filling, packaging & QA/QC; ensure FDA, EU, BIS & Drug Act compliance; conduct audits; review BMR, BPR & MFR; implement QMS; train staff on GMP/GLP; manage labelling, claims & documentation for regulatory compliance.

Company Name Gangwal healthcare Job Title Manager - production Job Location: Maharashtra Description Department: Production Location: Boisar/Tarapur Reports To: Sr. Production Manager / Plant Head Industry: Nutraceuticals & Food Manufacturing Employment Type: Full-time Job Summary The Manager Production is responsible for planning, organizing, supervising, and executing daily manufacturing operations in compliance with GMP, FSSAI, HACCP, and other regulatory requirements. The role includes managing resources, ensuring production targets, quality control, equipment efficiency, and safety standards. Key Responsibilities Production Planning & Execution: Assist in preparing and executing daily/monthly production schedules. Ensure timely and efficient production as per defined targets. Monitor batch processing, blending, granulation, encapsulation, tableting, coating, filling, and packing operations. Should have very strong command on Sensory/Flavouring of products. Should be capable to ensure organoleptic properties (taste, aroma, mouthfeel) meet product standards. Evaluate and optimize flavour profiles for powder, liquid, chewable, or gummy formats during scale-up and production. Participate in sensory panel testing and contribute to flavour improvement strategies. Ensure consistency in taste, texture, and appearance across batches. Sound knowledge of flavouring agents, sweeteners, masking agents, and natural/artificial additives. Hands-on experience in sensory evaluation techniques and hedonic scoring methods. Ability to identify off-flavours or formulation inconsistencies and suggest corrective actions. Compliance & Documentation: Ensure adherence to GMP, FSSAI, ISO, and HACCP guidelines. Maintain accurate batch manufacturing records (BMRs) and batch packaging records (BPRs). Participate in internal/external audits and ensure timely closure of CAPAs. People & Resource Management: Supervise and guide operators and line staff. Coordinate manpower planning, training, and performance monitoring. Quality & Process Control: Liaise with QA/QC departments to ensure quality standards. Implement and monitor in-process quality checks. Identify process deviations and initiate corrective actions. Maintenance Coordination: Coordinate with maintenance team for equipment calibration and preventive maintenance. Ensure operational readiness and cleanliness of equipment and utilities. Inventory & Material Handling: Ensure availability of raw materials, excipients, and packaging materials for uninterrupted production. Minimize wastage and monitor yield performance. Qualifications & Experience Education: B.Tech (Food Technology or equivalent) Experience: 7 to 10 years of experience in production in a Nutraceutical / Food / Pharma manufacturing plant Knowledge: Sound knowledge of nutraceutical or food manufacturing processes Familiarity with regulatory standards (FSSAI, GMP, HACCP) Proficient in BMR/BPR documentation Experience with machinery used in tablet, capsule, powder, and liquid formulations Skills Required Strong leadership and team management skills Excellent communication and coordination skills Analytical thinking and problem-solving Time management and multitasking abilities ERP and MS Office proficiency (SAP, Excel, Word) Apply Here [HIDDEN TEXT] Show more Show less

You will be working as a Production Chemist with a focus on knowledge of BRM, BPR, and exposure to GDP, GMP. Your role will involve experience in Sterile and Sterilization processes. As a Production Chemist, your responsibilities will include Batch Planning and Batch Manufacturing. The qualifications required for this position include relevant education details. The required skills for this role are a strong knowledge of BRM, BPR, exposure to GDP, GMP, and experience in Sterile and Sterilization processes. Preferred skills include proficiency in Batch Planning and Batch Manufacturing. Our company is committed to diversity and inclusivity, promoting an equal opportunity environment for all employees.,

As a key member of the Company OE projects team, you will actively participate in Business Transformation Projects encompassing roles in Business Analysis, Consulting, Offshoring, Project Management, and Process design/ Re-engineering (BPR). This diverse role offers real-world consulting experience with a global perspective and provides opportunities to engage in various Business-related endeavors. Your primary responsibilities will include: Consulting responsibilities: - Leading customer meetings to assess business problems and identify opportunities within OE business groups. - Analyzing and interpreting data to uncover weaknesses and problems, understanding their root causes. - Formulating recommendations for business and structural changes to enhance efficiency, profitability, performance, or a combination of these areas. Project Management responsibilities: - Leading Consulting, Business Transformation, or strategic Projects & Programmes for OE India utilizing Project/Programme Management skills. - Ensuring effective and sustainable solutions by managing project timelines, deliverables, troubleshooting, conflict resolution, communication management, and stakeholder engagement. - Assessing the impact of change on project costs, timescales, and resource requirements. Process Improvement & Business Analysis responsibilities: - Identifying opportunities for continuous process improvement and implementing solutions using OPEX/Lean methodology/tools. - Collaborating with business stakeholders to gather and analyze requirements, documenting processes, procedures, and solutions accurately for reporting and knowledge retention. Customer Relationship Management Responsibilities: - Establishing strong relationships with customers and serving as the primary point of contact for engagements. - Proactively addressing risks and issues in customer relationship meetings. Other Responsibilities: - Providing guidance and mentorship to Associate Business Consultants and Business Consultants, delegating complex tasks and promoting ownership of performance and development. - Serving as an escalation point/back up in the absence of Manager Business Consulting. Qualifications & Experience: - Graduate/postgraduate in any discipline. - Minimum of 7 years of experience in Consulting, Business change Projects, Business Analysis/Project Management & Process Improvement within the insurance/BFSI domain. - Experience in managing end-to-end business transition projects, process reengineering projects, consulting projects, and program management is required.,

As an IPQA Specialist in an API manufacturing environment, your primary responsibility will be to monitor production activities and ensure cGMP compliance on the shop floor. You will be required to review and approve Batch Manufacturing Records (BMR), Batch Cleaning Records (BCR), and related analytical records before releasing API. Preparation and revision of SOPs, BMRs, BCRs, and other QA-related documents will also be part of your duties, aligning them with regulatory and internal requirements. Sampling of APIs, maintaining related records, overseeing proper cleaning and maintenance of sampling tools, and managing storage of control samples of API will be crucial tasks to uphold quality standards. Line clearance at each product changeover stage, coordinating dispatch processes, and supporting investigations of deviations and incidents with the QA Head/Designee are essential aspects of your role. Your involvement in Product Quality Reviews (PQR) for all APIs will require compiling relevant data and identifying areas for improvement. Monitoring process and cleaning validation activities on the shop floor to ensure compliance, supporting data integrity, documentation practices, and preparing for audits are integral to maintaining quality standards. Your collaboration with production, QC, engineering, and warehouse teams will be vital for addressing day-to-day IPQA requirements. Additionally, participation in risk assessments, change controls, CAPA implementation, and training QA executives and production personnel in cGMP, documentation, and in-process control requirements are part of your responsibilities. Handling quality events such as market complaints, recalls, and audit observations, contributing to continuous improvement initiatives, ensuring readiness and compliance for inspections and audits, and leading QMS enhancements and harmonization of documentation practices are key aspects of your role. Maintaining logs, registers, and master data related to IPQA activities, monitoring and reporting compliance KPIs to QA management, and representing QA in daily production meetings and batch release discussions are also part of your duties. **Qualifications:** **Education:** - Required: B.Sc in Organic Chemistry - Preferred: M.Sc in Organic Chemistry, B.Pharm / M.Pharm **Experience:** - 8 to 10 years of relevant experience in IPQA within an API manufacturing environment **Skills:** - Advanced knowledge in IPQA & Line Clearance Activities - Advanced expertise in Batch Documentation Review (BMR, BCR, BPR) - Intermediate to Advanced proficiency in Process & Cleaning Validation Oversight - Intermediate skills in Deviation/Incident Investigation - Intermediate understanding of Control Sample & Sampling Procedures - Advanced knowledge of cGMP & Data Integrity Compliance - Intermediate skills in QMS Documentation & SOP Preparation - Intermediate proficiency in Product Quality Review (PQR) - Advanced competence in Shop Floor Quality Monitoring - Intermediate to Advanced abilities in Cross-functional Communication & Coordination,

As the Quality Control Officer, you will be responsible for ensuring the overall quality of products and compliance with GMP at the site. This includes conducting line clearance prior to dispensing, manufacturing, packing, and validation activities. You will also be involved in sampling during the manufacturing of validation, exhibit, and commercial batches, as well as in-process control, routine inspection, and online process verification and documentation. Your duties will involve the preparation, review, and approval of various documents such as SOPs, BMRs, BPRs, SMFs, VMPs, APQRs, MFR validation protocols/reports, and qualification protocols/reports. Additionally, you will be responsible for executing and evaluating qualification and validation studies, as well as evaluating and authorizing rework or reprocessing of batches. Your role will also include reviewing batch documentation and releasing batches for distribution, and ensuring quality control functions to maintain GLP and data authenticity. Furthermore, you will review and approve worksheets, COAs, raw and packing material specifications, semi-finished specifications, finished product specifications, and stability protocols. You will also review stability data generated at the site and submit it to Regulatory Affairs for dossier preparation. Additionally, you will be tasked with controlling, distributing, retrieving, and destroying master and executed documents such as BMRs, BPRs, analytical workbooks, master SOPs, protocols, reports, and logbooks. Qualifications required for this role include a Bachelor's degree in Pharmacy or Chemistry, knowledge of cGMP, and a minimum of 3 years of experience in the Pharmaceutical industry. This is a full-time position with benefits such as food provided, health insurance, life insurance, paid sick time, and Provident Fund. The work schedule involves rotational shifts, and there is a yearly bonus offered. The work location is in person, and the application deadline is 20/06/2025, with an expected start date of 20/08/2025.,

The Supply Chain Executive is responsible for maintaining and monitoring Finished Goods (FG) made to stock (MTS), analyzing stock readiness, ensuring timely customer service, coordinating material movement, and supporting procurement planning through effective data management and reporting. The role requires strong coordination with cross-functional teams, especially Customer Care and Production Planning Control (PPC), to ensure smooth supply chain operations. 1. Finished Goods (FG) MTS Management Maintain FG MTS inventory to ensure readiness of materials for timely customer fulfillment. Analyze stock gaps against predefined inventory norms and highlight variances. Prepare and update the FG MTS Business Process Report (BPR) sheet regularly. Identify Stock Keeping Units (SKUs) requiring processing based on stock analysis. Coordinate with the Customer Care Department (CCD) for dispatch readiness and order processing. Issue material processing plans to the Production Planning Control (PPC) department. 2. Purchase Order (PO) Management Create POs for material movement including stock transfers within JSSL and stock lots received from JSL/JSHL. Modify existing POs as per operational requirements. Monitor pending POs and initiate closure of completed ones. Prepare and share LC (Letter of Credit) invoice reports with the Finance department. 3. Raw Material (RM) Procurement Planning Gather current stock and in-transit material information. Prepare Raw Material BPR using data from SAP and JSL material dispatch reports to support procurement planning. 4. MIS Reporting Data Analytics Prepare and circulate daily stock summary reports across JSSL, JSL/JSHL job work, and yards. Generate service center production performance reports. Compile and report stock details including RM dispatch from JSL/JSHL, yard inventory, and aged stock analysis. Provide data insights through structured MIS reports for management and relevant departments. Key Skills Competencies: SAP / ERP System Proficiency especially in inventory, procurement, and logistics modules Analytical Thinking ability to interpret inventory data and identify actionable gaps Communication Coordination strong collaboration with internal departments Excel/MIS Reporting advanced MS Excel skills and experience in report automation Time Management ability to manage multiple tasks and prioritize effectively Qualifications: Bachelors degree in Supply Chain Management, Logistics, Engineering, or related field 24 years of experience in a supply chain, logistics, or production planning role Experience in the steel/metals/manufacturing industry is preferred

Set up and manage the Project Implementation Unit for a 5-year duration. Improve access for businesses and beneficiaries to e-government services. Undertake Business Process Re-Engineering (BPR) and Government Process Re-Engineering (GPR) for identified service areas. Study existing business processes and organizational structures of government departments. Prepare as-is process maps and workflow charts to identify duplications and inefficiencies. Analyze gaps and propose to-be processes, including layers of decision-making, time analysis at each level, and required documentation. Ensure improved and efficient delivery of G2G (Government to Government), G2B (Government to Business), and G2C (Government to Citizen) services.

Division Department Sub Department 1 Job Purpose Monitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targets Key Accountabilities (1/6) Execute shift packing activity by managing available resources and reduces micro stoppage of machine to achieve shift target Utilise shift resources optimally to get desired production output Regulate usage of consumables in the production process at optimum level to save cost Key Accountabilities (2/6) Review documentation related to packing activity and monitor standard packing parameters as per BPR to meet regulatory requirement Review and monitor critical in-process parameters like NFD, camera challenge, RH temperature etc Review and perform all operations as per GMP and safety norms by reviewing all processes and documents for compliance Maintain system integrity by updating online documentation Perform qualification and calibration of equipment as per schedule and update output of all activities in the system Key Accountabilities (3/6) Prepare manufacturing records and update online documentation to meet production and cGMP requirement Maintain online documentation and timely entries in BPR and supporting documents by operating SAP and CipDox Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Monitor adherence to safety guidelines in the block during a shift for packing activities to create safe working environment Monitor safety systems and ensure procedures are followed in shift and near-miss cases are reported to HSE timely Ensure availability and usage of PPEs in the shift by coordinating with HSE department Ensure compliances to safety training targets by monthly reconciling attendance records Key Accountabilities (5/6) Provide training to staff & workmen for packing activity by regular interactions with them to get quality product Provide training to staff and daily workers for packing activities and safety procedures Conduct training related to equipment handling, cGMP, documentation and unit operations Key Accountabilities (6/6) Provide new ideas and simplify processes to reduce process cycle time and achieve new targets Provide new ideas during idea sessions for better productivity with minimum cost Identify the complexities and suggest process simplification areas to achieve new target with optimum utilization of resources Reduce and simplify documentation for better accuracy and to meet ALCOA (Attributable Legible Contemporaneous Original Accurate) Major Challenges Meeting shift target due to unavailability of adequate resources Overcome by efficient work load distribution Maintaining cGMP requirements during system downtime Overcome by coordinating with engineering and technical support team Key Interactions (1/2) Quality assurance and control for batches release as per packing plan (Daily) Engineering for preventive maintenance and help in modification (as per need) Safety for awareness training and near miss issue (Daily) Store for daily dispensing plan and availability of packing materials (Daily basis) Key Interactions (2/2) Maintenance contractor for any machine repairs (Need Based) Dimensions (1/2) Direct Reports : 3 Achieve average volume of 200 mn (FY2015-16) Average number of BPRs handled : 200 Average number of batches in packing : 200 Average number of sales order dispatched : 80 Achieve internal OTIF more than 90% Achieve Zero reportable accidents/ incidences during packing activities Achieve 0% errors in online documentation Meet 100% compliance to SOP and Safety regulation Dimensions (2/2) Key Decisions (1/2) Resources allocation and work distribution for each shift Key Decisions (2/2) Up-gradation in facility and documents to Section Head Packing Modification in equipment to Section Head Packing Deviation and implementation of CAPAs Section Head Packing Education Qualification Pharm Relevant Work Experience 1-5 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents Show

Responsible for leading production operations, coordinating production staff and equipment, ensuring product quality and profitability, and overseeing and managing the production operations involved in injectable products.

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

The candidate will be responsible for the proper receipt, storage, and GMP-compliant dispensing of raw materials used in pharmaceutical production Perform raw material dispensing activity in designated dispensing booths under controlled conditions.. Required Candidate profile Receive, inspect & label incoming raw materials as per SOP Coordinate with the QA, Production & QC department during material movement Ensure adherence to GMP, GDP & safety guideline during dispensing

To perform IPQA activities at shop floor in every stage of OSD manufacturing and packing. Review of BMR & BPR. Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. Review of documents of respective areas and logbooks for adequacy and completeness. QA overview for receipt of material from warehouse to production. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. Preparation & Review of process validation protocols and reports. Any job activity assigned by HOD

Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 2-4 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.

As an intern at ThinQ Pharma, your day-to-day responsibilities will involve assisting in formulation and pre-formulation studies, supporting the development of stability and bio batches, helping in maintaining lab records including BMR/BPR and SOPs, coordinating with cross-functional teams such as QA/QC/Production, and performing basic lab tests while ensuring accurate data recording. ThinQ Pharma is an integrated pharmaceutical company with a strong global presence and a reputation for offering world-class products and services. Headquartered in Singapore and operating a fully equipped research center in Mumbai, India, ThinQ Pharma has been a key player in the global market for more than 25 years. With a highly skilled team, the company is committed to providing comprehensive solutions for the pharmaceutical and wellness industries.,

To perform IPQA activities at shop floor in every stage of OSD manufacturing and packing. Review of BMR & BPR. Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. Review of documents of respective areas and logbooks for adequacy and completeness. QA overview for receipt of material from warehouse to production. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. Preparation & Review of process validation protocols and reports. Any job activity assigned by HOD

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. 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.