1778 Gmp Jobs - Page 46

01 To 02 Year in years of experience in Quality Control in an Ayurvedic / herbal / pharmaceutical company. Education Qualification: M.Sc | B.Pharm |M.Pharm (Ayurveda or Pharmaceutics preferred). Department: Quality Control Ayurvedic Location: Santej Ahmedabad. * Transportation Facility Available (As Per Circumference Of Sunrise Remedies) Mediclaim and Food Facility provide By Company. Key Responsibilities: Conduct routine quality checks and testing of raw materials, packaging materials, in-process samples, and finished Ayurvedic products. Ensure compliance with AYUSH regulations, GMP, and ISO standards where applicable. Maintain and calibrate lab instruments such as HPTLC, UV-Vis Spectrophotometer, pH meters, etc. Prepare and maintain Standard Operating Procedures (SOPs), test reports, COAs, and specifications for materials and products. Conduct microbiological testing and stability studies as required. Collaborate with the production, and QA departments for troubleshooting and quality-related investigations. Handle non-conformance reports (NCRs) and support in CAPA implementation. Review batch manufacturing records (BMRs) and ensure quality documentation is in place. Support in regulatory audits (AYUSH, FSSAI, WHO-GMP, etc.) and third-party inspections. Please drop your CV or Resume to info@sunriseremedies.in Our HR Department will get in touch with you.

Coordinate to ensure minimum stoppage during shift Ensure manpower allocation as per planning. Regularly checking the Production Rate as per the quality standards Maintain all the register for process parameters Checking stage wise process samples Perks and benefits Medical, Canteen

- Analysis of finished goods & RM & maintain its documents - Analysis of all products as per inspection plan - Conduct the in- house calibration of instrument and equipment - Laboratory reagent preparation, its standardisation for daily use Perks and benefits Medical, Canteen

Managing all production activities during the assigned shift. Operating equipment’s Reactors, Centrifuges, and Dryers. Ensuring adherence to SOP, GMP and other relevant regulations. Maintain accurate production records, Online BMR, BPCR feeling.

Job Role: Overall responsibility of quality assurance & food safety for Snacks category (includes Potato Chips, Extruded & Fried Snacks, Traditional namkeens, Sweets and similar products) manufactured at third-party locations and/or RCPL sites, successful implementation of RCPL quality systems, setting up monitoring & testing protocol for various quality parameters, third-party mfg. locations audits, training and driving quality culture. Key Responsibilities: 1. Compliance with RCPL Quality Standards: • Develop & communicate RCPL Quality Standards & Technical-manuals for SNACKS category • Implement & maintain RCPL quality standards & processes at 3P locations • Ensure incoming RM/PM or ingredients in compliance with RRL specifications & correct test methods are used by site team • Ensure process specifications are met and in compliance with RCPL specs • Ensure FG specifications are met and in compliance with RCPL specs (e.g. pack weights as per W&M rules, batch coding, seal integrity, sensory of products etc.). Verify production for the late-night shifts before dispatched to market • Timely communication of any deviations of specs for RM, PM., Processes, FG to TCM, Site team and RCPL category leads. Follow through for immediate closures and updates • Ensure FG & water are tested from an accredited lab as required by regulators • Ensure HACCP SOPs are successfully implemented and followed for 3P sites • Ensure basic GMPs/HK practices are followed by site team and follow up for corrections for observed gaps with site team • Ensure daily/monthly/quarterly GMP/HK/Pest control etc. checks or audits are conducted by site team and support them for conducting inspections. Follow through with site team for gaps closures • Ensure or provide necessary food safety/GMP/process/lab training etc. to the site team on periodic basis and/or follow through with site team for any required external training needs • Conduct periodic audits of 3P sites against RCPL quality standards and/or HACCP or FSSC 22000 procedures. Key Competencies required: 1. Functional Competencies: a. SME on Snacks processing- Potato Chips, Namkeen & Sweets (experience preferred) b. Technical excellence c. HACCP & risk assessment for Snacks category d. Audits (suppliers and mfg. locations) e. Snacks projects (preferred) f. Specification management g. Process management h. Complaints handling i. Driving Snacks productivity (preferred) j. Knowledge on Regulatory compliance 2. Behavioral Competencies: a. Action oriented b. Drive for results c. People/team management d. Networking & effective stakeholders management e. Problem solving f. Coaching & training the teams

The ideal candidate will bring in-depth experience in pharma warehouse operations, with a proven track record of managing large-scale warehouse functions efficiently at ALC Noida

The ideal candidate must have prior experience in pharma warehouse management, with a strong understanding of compliance, inventory control, and efficient warehouse practices at our ALC Baruipur facility.

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other duties as assigned. Job Requirements: Education M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 3 to 6 years of experience in GMP regulated pharmaceutical industry.

Experienced QA Manager to oversee&manage QA operations our pharmaceutical manufacturing unit.Ideal candidate will ensure compliance with GMP, WHO other regulatory standard,while developing &maintaining QMS Share your Resume to hrd@stedmanpharma.com

Role & responsibilities Responsible for the development of Standard Operating Procedures, standards and support in competency building of co-mfg. site teams as per organization requirements Development and support in setup & approval of new Co-manufacturing partners and expansion of the existing partners facilities wrt Food safety, Hygienic engineering, Pathogen monitoring plans, Plant Cleaning & Sanitation, Pest management, Quality monitoring schemes, Process validations & Compliances requirements and best practices. Accountable for adherence of end-to-end quality management and advising the business & procurement on key quality & process strategies in terms of CAPEX @ co-manufacturer end. Ensuring Compliance to First Time Right and seamless throughput for achieving planned targets. Implementation of Quality systems & compliances requirements with respect to Regulatory for all plants. Routine audits of co-manufacturing, raw material & packaging material vendors sites for Food safety & compliance evaluation Coaching and Developing Quality & Process verticals (Food Safety, HACCP, Product QA & NPD, RM PM, Sensory, Compliances, Consumer complaints & Plant In-charges) on functional and leadership competencies. Ensuring Continuous Excellence, Operational savings and budgetary controls. Experience in handling authorities & consumer visits in terms of authority deviations, notices & critical complaints Preferred candidate profile Ideal Candidate – B. Tech / M. Tech in food Technology from premier institutes having 15 to 20 years’ experience in Food, Savories, Beverages, Should have worked in tier one companies, MNCs Should have experience in the entire areas of Quality, RM, PM, HACCP, Food safety, Development of standards, QMS, Auditing & Certification Audits, Sensory Management, NPD, Risk assessment, Storage, Transportation etc Should be willing to work out of Rajasthan Location (Bikaner) Should be experienced in handling multi-location Plants and contract manufacturing plants. Should have excellent communication and presentation skills.

Manage entire technology transfer from R&D to manufacturing. Lead pilot plant trials/scale-up protocols Work closely with Production/QA/EHS teams Conduct fit-gap assessments Monitor pilot batches/readiness for commercial launch Required Candidate profile 4+ yrs exp in tech transfer/pilot scale-up in API, in Pharma cos. Familiar with distillation/extraction/solvent recovery/filtration/drying system Expert in GMP/EHS practices

Job Description 10-15 Years Experience in managing google analytics Google Tag Manager & Google Analytics Management: Oversee the implementation, configuration, and maintenance of GTM and GA4, ensuring accurate and consistent data collection across websites and mobile apps. Data Tracking & Reporting: Manage the intake process for tracking and reporting requests from business partners, prioritizing requests, and ensuring timely implementation. Continuous assessment: Analyze performance, identify areas and Make data-driven recommendations for improvement in website/app user experience, marketing strategies, and digital channels. Work hours: Available for meetings and discussions until 12 noon CST Soft Skills: Excellent written and verbal communication, presentation, attention to detail and business acumen skills. Documentation: Maintain clear and comprehensive documentation of tracking implementations, configurations, and processes. Azure DevOps Management: Utilize Azure DevOps (Visual Studios) to manage Epics, Features, and User Stories related to data tracking and reporting initiatives. Google Marketing Platform (GMP) Expertise: Leverage other GMP products (e.g., BigQuery, Google Ads, Search Console) as needed to enhance data analysis and reporting capabilities. Data Analysis & Insights: Conduct in-depth analysis of custom events, channel performance, campaign effectiveness, and funnel conversion rates, providing actionable insights and recommendations. User Journey Analysis: Map out user journeys, analyze user behavior, and identify opportunities for optimization across various channels, campaigns, and funnels (e.g., e-commerce, lead generation). KPI Development & Measurement: Define and implement key performance indicators (KPIs) aligned with business objectives, providing regular reporting and analysis on performance across multiple business units/brands. Process Improvement: Collaborate with Business Systems Analysts and Business Analysts to optimize the tracking and reporting request process, creating and prioritizing User Stories within Azure DevOps. Cross-Functional Collaboration: Act as a liaison between Product Management, Developers, Business Systems Analysts, Business Analysts, and other stakeholders to translate business requirements into technical specifications for data tracking. Qualifications Bachelors degree in Marketing, Business, Analytics, Computer Science, or a related field. Proven experience (10+ years) in digital analytics, with a strong focus on GTM and GA4. Deep understanding of web analytics principles, data tracking methodologies, and digital marketing KPIs. Proficiency in configuring and managing GTM containers, tags, triggers, and variables. Experience with GA4 implementation, event tracking, custom dimensions/metrics, and reporting. Familiarity with other GMP products (BigQuery, Google Ads, Search Console) is a plus. Experience working with cross-functional teams and managing stakeholder expectations. Strong analytical skills, with the ability to translate data into actionable insights. Excellent communication, presentation, and interpersonal skills. Experience using Azure DevOps (Visual Studios) or similar project management tools. Experience with SQL is a plus.

We are seeking a meticulous and experienced Executive/Sr. Executive to spearhead chromatographic analysis and data review at Synnat Pharma Private Limited, a rapidly growing API manufacturer. In this pivotal role, you will be responsible for ensuring the accuracy, reliability, and compliance of analytical data generated within our QC laboratory. Your expertise will be crucial in adhering to stringent regulatory standards, including ICH guidelines and pharmacopeial requirements, while contributing to the overall quality and integrity of our pharmaceutical products. The ideal candidate will possess a strong understanding of HPLC and GC systems, coupled with proficiency in Empower CDS and a deep commitment to data integrity and GLP/GMP principles. This role demands a proactive individual capable of troubleshooting analytical issues, leading OOS/OOT investigations, and implementing effective CAPA measures. You will collaborate closely with cross-functional teams to maintain a robust Laboratory QMS and ensure seamless method of transfer and validation processes. If you are passionate about pharmaceutical sciences and dedicated to maintaining the highest standards of quality in API manufacturing, we encourage you to apply. Job Details: Industry: Active Pharmaceutical Ingredient (API) Manufacturing Department: Quality Control Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 4,00,000 to 8,00,000 INR per annum Experience: 4-7 years Qualification: Bachelor's or Master's degree Chemistry, or a related field Employment Type: Full-time Responsibilities: Chromatographic Analysis and Data Review Perform chromatographic analysis of raw materials, in-process samples, and finished products using HPLC and GC techniques, ensuring compliance with established test procedures and pharmacopeial requirements. Review chromatographic data generated by other analysts for accuracy, completeness, and compliance with data integrity and GDP. Troubleshoot HPLC and GC systems, resolving issues to ensure reliable instrument performance. Participate in method validation and transfer activities in line with regulatory expectations. Analyze stability samples and maintain data integrity in accordance with ICH guidelines. Prepare reports summarizing analytical results and findings. Quality Control and Compliance Implement and maintain a robust Laboratory QMS as per GLP, GMP, and internal quality standards. Lead OOS and OOT investigations and implement corrective actions to prevent recurrence. Manage and document CAPA activities effectively. Ensure data integrity through robust controls and secure data handling practices. Participate in audits and address regulatory observations. Maintain accurate documentation as per GDP guidelines. Laboratory Operations and Maintenance Oversee calibration and maintenance of HPLC and GC systems. Manage lab supplies and ensure proper storage and inventory control. Maintain a clean and compliant lab environment. Train junior staff in instrumentation, methods, and data practices. Develop SOPs and contribute to continuous improvement of test procedures. Support cross-functional teams in resolving quality-related issues. Stakeholder Management and Reporting Collaborate with R&D, production, and regulatory affairs teams. Communicate analytical findings effectively for decision-making. Prepare periodic reports for management summarizing QC trends. Participate in regulatory inspections and audits. Coordinate with external vendors for analytical services. Represent the QC department in internal/external meetings. General Expectations and Past Experiences: Possess a Bachelor's or Masters degree in Pharmaceutical Sciences, Chemistry, or a related field. Have 4-7 years of experience in a pharmaceutical QC lab, preferably API-focused. Demonstrate expertise in HPLC and GC, including troubleshooting and method validation. Exhibit a strong understanding of GMP, GLP, ICH, and pharmacopeial compliance. Proficiency in Empower CDS is essential. Strong skills in data review, OOS/OOT handling, CAPA, and documentation. Excellent team collaboration, problem-solving, and communication abilities.

Job Opening: Field Quality Executive Location: East Region Company: Devyani Food Industries Ltd. Position: Full-Time Experience Required: Minimum 04-06 years (Ice Cream preferred) Salary: As per industry standards Job Summary: We are looking for a Field Quality Executive. The ideal candidate will be responsible for overseeing or assessments are required the management of cold rooms and deep freezers, maintaining push carts and collaborating with other departments to optimize operational efficiency and quality compliance. Covers tasks from product verification , defect analysis, customer feedback resolution and reporting .Submit daily summaries report to the Head of the Quality Assurance & Head of the Sales department. Key Responsibilities: Daily planning for review inspection schedules and customer visit plans, coordinate with sales Teams and ensure availability of required the test equipment, documentation , temperature thermometer & Log Sheets. Verify conditions of the vehicles, handling and usage practices ,inspect product quality and packaging integrity and check compliance against SOPs, product specifications and customer expectations. Maintain time and daily reports for visiting the site while observed the issues and take action , gather complaint details and inspect the product in question and conduct root cause analysis, The area around deep freezers must be clean, with no dirt or debris. Avoid overloading deep freezers, as this can prevent them from maintaining the correct temperature , leading to product melting, sogginess , deformation or other defects. There should be no ice formation within the deep freezer. Ensure the Product Temperature maintains a temperature of 18C or below. All crates should be positioned at least 1.5 feet away from the walls. Stacking crates should not exceed the height of the cooling unit to ensure proper air circulation around all products. Train field teams or vendors/ Distributors on basic quality requirements of product checks and handling. Participate in regular review & updating. Document feedback and improvement suggestions from the field. Candidate Requirements: Bachelors/Diploma in Dairy Technology years of experience in a production role (preferably in ice cream, dairy, or frozen dessert sector) How to Apply: Interested candidates can send their updated resume to tanusree.nag@creambell.com

Role & responsibilities Handling Administration management and Goods Manufacturing Practice Preferred candidate profile Goods Manufacturing Practice

Work Experience 1-5 years Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i.e.: Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Education Masters in Life Science Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i.e.: Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Work Experience 1-5 years Education Post Graduation in Life Science or Biotechnology Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Location : Krishnapatnam City : Krishnapatnam State : Andhra Pradesh (IN-AP) Country : India (IN) Requisition Number : 40201 Business Title: Officer-Ammonia Global Job Title: Sup Sp III Eng/CAPEX PM Global Function: Industrial Operations Global Department : Industrial Operations Reporting to: Manager-Packaging Role Purpose Statement: Ensure smooth running of utility equipment s and Vanaspati Production with quality and Food Safety Main Accountabilities: Operate and Maintain the packing utility equipment (Chillers, air compressor, ammonia system, cold rooms, cooling towers, Air Dryer) Ensure to maintain cold room cycle and timely Vanaspati FG delivery to dispatch. To record and monitor the equipment parameters in shifts. Operate the refinery & bakery ammonia plant. Follow the Safety & food safety Standards & HACCP standards. To conduct pre shift risk assessment and Tool box talk with the entire team.. Ensure the proper utilization of manpower. Sustain the 5s & housekeeping in ammonia plant. Ensure the online quality check of cold room parameters. Ensure to clean & dry vanaspati tins and Timely handover to dispatch Regular machine health check-up and follow maintenance of machine as per schedule. Minimize wastage and damage in respect to oil and packing materials. Maintain the shift records and log book and proper hand over take over. Knowledge and Skills: Behavior Use knowledge of Bunge s business, structure and strategy to develop innovative solutions to improve results or eliminate problems. Build partnerships, appropriately influence to gain commitment, foster talent and coach others to grow in current or future roles.. Drive results through high standards, focus on key priorities, organization, and preparing others for change." Technical Sound Knowledge of Chillers, air compressor, ammonia system, cold rooms, cooling towers, Air Dryer. PM, Trouble shooting, DCS/ SCADA operations, GMP Education & Experience: ITI/Diploma 5 to 8 years Bunge is an Equal Opportunity Employer. Veterans/Disabled

Position Title Lead Consultant - Capital Project Management Function/Group Position Title Location Mumbai Shift Timing 1:30 PM 10:30 PM IST Role Reports to Senior Manager Engineering Solutions Remote/Hybrid/in-Office Hybrid About General Mills We make food the world loves: 100 brands. In 100 countries. Across six continents. With iconic brands like Cheerios, Pillsbury, Betty Crocker, Nature Valley, and Haagen-Dazs, we ve been serving up food the world loves for 155 years (and counting). Each of our brands has a unique story to tell. How we make our food is as important as the food we make. Our values are baked into our legacy and continue to accelerate us into the future as an innovative force for good. General Mills was founded in 1866 when Cadwallader Washburn boldly bought the largest flour mill west of the Mississippi. That pioneering spirit lives on today through our leadership team who upholds a vision of relentless innovation while being a force for good. For more details check out http://www.generalmills.com General Mills India Center (GIC) is our global capability center in Mumbai that works as an extension of our global organization delivering business value, service excellence and growth, while standing for good for our planet and people. With our team of 1800+ professionals, we deliver superior value across the areas of Supply chain (SC) , Digital & Technology (D&T) Innovation, Technology & Quality (ITQ), Consumer and Market Intelligence (CMI), Sales Strategy & Intelligence (SSI) , Global Shared Services (GSS) , Finance Shared Services (FSS) and Human Resources Shared Services (HRSS). For more details check out https://www.generalmills.co.in We advocate for advancing equity and inclusion to create more equitable workplaces and a better tomorrow. Job overview Function Overview The GIC supply chain team manages end-to-end operations, encompassing planning, sourcing, manufacturing, logistics, and analytics. They strategically plan to meet market demands, optimize sourcing, ensure efficient production, and oversee the seamless movement of goods from production to delivery. The team employs advanced analytics throughout these processes, fostering adaptability and operational excellence. This collaborative approach ensures a well-coordinated supply chain that aligns with both organizational goals and dynamic market conditions. For more details about the function please visit this Link Purpose of the role The GIC Engineering Project Manager is responsible for supporting a US-based Project Manager in leading and providing technical expertise for capital projects in a multi-discipline team environment. Responsibilities include collaborating with diverse teams and functional areas and effectively communicating with key clients and stakeholders across the NAR, NAF, and PET segments. You will work cross-functionally with site operations, maintenance, engineering, and external partners (design firms, contractors) to deliver high-quality solutions that support efficient, sustainable manufacturing. Key Accountibilities Provide project management support to assist with leadership on capital project installations with business teams and key stakeholders including scope definition, budget development, resource selection/management and schedule management. Provide capital project estimating support for cost, scheduling and technical performance as needed by the business units. Provide support for IRR and sensitivity analysis regarding options and proposals in support of the business units. Support the assembly of the required long lead project(s) and capital definitive project. Provide support to secure, organize and lead the resources necessary to successfully execute US managed projects. Support the cash flow analysis for the project. Support communication to the respective Engineering Business Managers and Initiative Leaders in the pertinent aspects of capital investment and implementation. Support the management of projects to meet the essential requirements of: o Technical/quality performance o Project Charter and Manufacturing requirements o Schedule o Capital budget o Start-up budget Assist in establishing basic project philosophies, procedures and challenges and refine with team input. Support the project team in required decision-making processes throughout the project life-cycle. Support the collaboration with the Start-up Manager, Lead Engineers and Systems Engineer(s) in establishing communications meetings. Assist in the management of the engineering resources as support to the production start-up. Support the project close-out process to ensure the integrity of the punchlist and a timely financial close. Participate in post-project review with Plant and support compliance with requirements and ultimate sign-off on project. Requires travel, including some extended time possibilities over weekends and holidays. Travel is variable, ranging from 0% to 10% during project execution and start-up, with an overall average of approximately 5%. Minimum Qualifications Bachelor of Science degree in Engineering or related degree with applicable experience or extensive relevant work experience 15+ years of relevant experience managing capital projects in manufacturing (preferably food or FMCG sector). Proven track record of delivering plant upgrades, new installations, or greenfield/brownfield projects. (preferably food or FMCG sector). Experience collaborating with international teams or within a corporate environment. Ability to travel occasionally to the United States Experience in plant operations and industrial environments understanding equipment design and impacts to materials, labor, and work processes. Thorough understanding of food safety, human safety & environment policies, processes, and compliance. Project Engineering experience including scope definition, cost estimation and tracking, EAC estimation and scope management. Experience working successfully with teams. Demonstrated performance in executing concurrent assignments. Strong technical leadership skills in a collaborative fashion. Capable analytical problem solver using data and keen judgment. Adaptability to maneuver through uncertainty with a high degree of professionalism and candor. Prefeered Qualifications Project Management Professional (PMP) certification. Strong project planning and execution skills Understanding of food processing and packaging technologies. Sound knowledge of utility systems (HVAC, boilers, water treatment, compressed air, etc.). Expertise in EHS (Environment, Health & Safety) and statutory compliance during project execution. Understanding of Food Manufacturing Regulatory Requirements (GMPs, Food Safety, sanitation practices and design criteria.) Familiarity with Continuous Improvement and Vertical Start-up tools and processes. Must Have Skills Mandatory hands-on capital project management experience in the Food or FMCG industry, including high-value and complex projects.

Designs the Quality Management System that standardizes and documents all processes. Ensures compliance to contractual deliverables and addresses team-level issues. Implement initiatives and projects as needed in order to drive performance. Ensures that all Quality SLAs are met. Designs and drives KPIs and KRAs of the team. Coordinates with all departments in implementing Quality Programs. Conducts projects to improve performance. Develops plans to minimize cost and increase productivity. Plans for manpower requirements and implemented right sizing of the department when needed. Creates process documentation and standardizes processes of quality. Conduct training for quality as needed. Develop the quality team in accordance with the quality roadmap.

Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i. e. : Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Work Experience 5-10 YEARS Education Post Graduation in Life Science or Biotechnology Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Job Description Visiting to Quality Control Labs to ensure that activities are being carried out by following GMP requirements and as per approved procedures. To ensure that labs are maintained to be GMP ready always. Follow-up to close the findings as per established procedures. Handling of QC Lab incidents, Deviations, change controls, OOS, OOT, OOL, QRM, CAPA management and related investigations throughout the year. Verification of analytical test results and approval through SAP. (In-process, Intermediate, DS, FB, DP and additional study reports if any). Batch Release activity for intermediates and In-process (i. e. : Media, buffers and so on). Review of SOPs/ STPs/ Specifications and any other documents as per GMP requirements for QC/QA department. Ensure that stability studies/ testing of samples are being carried out by following approved procedure/protocols. Work Experience 7-12 Years Education Post Graduation in Life Science or Biotechnology Competencies 1. Strategic Agility 2. Innovation & Creativity 5. Result Orientation Quality Technical Skills

Job Description Housekeeping: 1) Daily monitoring and upkeep of the GMP Manufacturing area, Lab Areas, as per the SOP guidelines. 2)Daily upkeep and monitoring of Common areas (Canteen, Corridors, Staircases, Washrooms, Roads and Garden etc. Through facility management agencies and ensure proper cleanliness of the facility for 24x7, at all times. Removal of Non-Hazardous Scrap from facility - ensure timely removal of scrap & its periodic disposal. GMP Compliance & Departmental SOP: Timely Preparation, revisions of departmental SOPs. :1) Timely compliance for all the observations related to Admin in internal and external audits. 2) Maintaining & Keeping all GMP Compliance record of Admin SOP s, logbooks, bound books etc. and its timely archival. 3) SPOC for all the QMS. Contract Labour Management: 1) Ensuring compliances with respect to contract labour like their PF, WC, Registers, Bonus, returns, minimum wages etc. 2) Ensuring the department wise daily deployment of skilled, unskilled manpower as per approved budgeted manpower. 3) Resolve Day to day grievances if any. General Administration: 1) Canteen: Daily check menu for Canteen 1and 2, working of Vending Machine, Canteen Contractor Manpower for its health and hygiene, ensure availability of the food, tea and its services on schedule time etc. Evaluate SLA vs. Deliverables and appropriate action as per SLA. 2) Security Management: day to day coordination with security departments for various implementations and information. 3) Visitor Management: Hospitality preparations for all the Local and International Visits, Guest, VIPs and Auditors etc. (Conference room readiness/cleaning /welcome board, food and beverages arrangements etc. 4) Garden: Daily interaction and follow up with Landscaping and Garden contractor for maintain green belt. 5) Office Furniture & Seating Arrangements: Ensure timely repair and maintenance of Office Furniture & seating arrangements for ne joiners as per plan 6) Petty Cash: Manage Petty cash requirement, SAP & Workflow for processing of Administration vendors bills & timely payment. CAPEX & OPEX Budget and Vendor Payments: 1) Ensuring the data availability and perseverance of expenses record/summery for Preparation and monitoring of CAPEX and Revenue Budget for Biotech Administration 2) Receipt and processing of vendor invoices as per the FSSC system/SAP/ARIBA etc. 3) Suggest new ideas for Cos Saving /Innovation etc. Government and Local Liaisoning, Govt. Compliances: 1) Factory License: Providing support to Admin Manager for Renewal, Extension and other activities related factory license at Biotech Facility. 2) Labour Compliances: Providing support to Admin Manager for Contract labour registration certificate, listing and delisting of vendors, minimize overall manpower and vendor numbers on RC, timely Renewals. 3) Coordination with HR/Legal team for matters related to labour office, court etc. in absence of Admin Manager. 4) Liaison with Police station -Paud and Pirangut, SP Rural as and when required. 5) Timely payment of Grampanchyat taxes, Facilitation for Grampanchyat and Tehsil work if any. Work Experience 5-6 Years of Experience with Pharma background. Education Graduation in Science Masters in Business Administration Competencies

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Position Objective : Support to manages all company Food Safety Management through implementation and maintenance of Quality Assurance system of Group and procedures that ensure product compliance to FSSAI and customer specifications Roles & Responsibilities Implement defined QA systems and process in Plant and at suppliers location. Manage the customer complaint redressal process which includes but not limits to follow up activities and verification of correction action. Partner with operation to train on QA systems and processes. Monitor and liaison with product owners to resolve product quality or operational issues. Manage and Summarize suppliers audit reports with solutions to the problems and prioritizing the most important opportunities for Quality, safety and cleanliness improvements at all level. Develop a strong professional relationship and communication with the industry associations & market to keep updated on the development related to food. Follow up with suppliers on validation of their lab testing methods which correlate with testing methods and procedures of local regulatory labs to ensure total compliance. Coordinate with training and operations management to provide training on food safety systems and technical advice to prevent food safety problems. Work closely with Operations and Training management to establish quality and safety measurement systems so opportunities for improvement are identified and acted on. Leverage technical resources of key raw material suppliers to provide training and product information at shop level. Support introduction of new suppliers as per the OYI Supplier guidelines. Skills Strong knowledge of Food Safety Systems and practices to Food Hygiene, Sanitation, SSOPs, GMPs Experience and knowledge of ISO 22000, ISO 9000 and certifications in auditing principles Please go the JD and If you are interested, kindly share your updated resume along with the following details : Few bullet points on Current CTC (fixed plus variable) Offer in hand (fixed plus variable) Expected CTC Notice period Experience on Food Manufacturing Plant Contact us Email:sp@intellisearchonline.net Mobile: 9590270707