68 Vendor Qualification Jobs

We seek a passionate Product Development Food Technologist to spearhead the creation of innovative and nutritious food products for babies, pregnant mothers, and new mothers at Rorosaur Foodtech Private Limited. As a key member of our New Product Development department, you will be instrumental in shaping the future of early childhood nutrition in India. This role encompasses the entire product lifecycle, from initial concept and formulation to nutritional and stability testing, label development, and ensuring compliance with FSSAI guidelines. The ideal candidate will possess a strong foundation in food science, a creative mindset, and a commitment to delivering high-quality, safe, and nutritious food products. You will collaborate closely with cross-functional teams, including sourcing, manufacturing, and marketing, to bring innovative products to market that meet the evolving needs of our consumers. Your expertise will be crucial in maintaining the highest standards of quality and safety, aligning with Rorosaur's mission to provide wholesome and convenient nutrition for infants and mothers. Responsibilities Product Formulation and Recipe Development Develop innovative and nutritious food formulations for babies, pregnant mothers, and new mothers, focusing on natural ingredients and optimal nutrient profiles. Design and execute recipe development, ensuring products are both palatable and nutritionally balanced. Optimize existing product formulations based on sensory evaluation, stability testing, and market feedback. Conduct thorough literature reviews and stay updated on the latest research in infant and maternal nutrition to inform product development decisions. Collaborate with the sourcing team to identify and qualify vendors for high-quality raw materials, ensuring compliance with Rorosaur's standards. Document all formulation and recipe development activities meticulously, including ingredient specifications, processing parameters, and nutritional information. Nutritional and Stability Testing Identify and implement improvements to testing methodologies to enhance accuracy and efficiency. Monitor and maintain accurate records of all testing activities, ensuring compliance with quality control procedures. Collaborate with external laboratories and research institutions to conduct specialized testing and analysis. Analyze test results, interpret data, and prepare comprehensive reports summarizing findings and recommendations. Conduct stability studies to determine product shelf life and identify potential degradation pathways. Plan and execute nutritional testing protocols to ensure products meet specified nutritional requirements and regulatory standards. Label Development and Regulatory Compliance Maintain a comprehensive database of all product labels and regulatory documentation. Work closely with legal and regulatory teams to address any compliance-related issues. Prepare and submit documentation for regulatory approvals, ensuring timely and efficient processing. Select appropriate FSSAI categories for new products, based on formulation and intended use. Stay up-to-date on FSSAI regulations and guidelines, ensuring products meet all applicable legal requirements. Develop accurate and compliant food labels, ensuring all required information is included and presented clearly. Manufacturing and Quality Assurance Provide training and support to manufacturing staff on product-specific requirements and quality control procedures. Investigate and resolve any quality-related issues that arise during production. Conduct regular audits of manufacturing processes to ensure compliance with quality standards. Participate in Hazard Analysis and Critical Control Points (HACCP) studies to identify and mitigate potential food safety hazards. Develop and implement Good Manufacturing Practices{GMP) to maintain a safe and hygienic production environment. Collaborate with the manufacturing team to scale up production of new products, ensuring consistent quality and adherence to specifications. New Product Innovation and Market Analysis Contribute to the development of Rorosaur's overall product strategy. Monitor competitor activity and analyze their product offerings to identify opportunities for differentiation. Develop and present product proposals to senior management, highlighting potential benefits and risks. Evaluate the feasibility of new product ideas, considering technical, economic, and regulatory factors. Generate innovative product concepts based on market insights and consumer feedback. Conduct market research to identify unmet needs and emerging trends in the infant and maternal nutrition market.

Following will be the responsibilities of the position holder: 1. To ensure cGMP compliance at site. 2. Responsible for Vendor Qualification and Management 3. Day-to-day coordination with QA-representative w.r.t. Vendor Qualification/Re-Qualification and Management status. 4. To review vendor documents for Vendor Qualification. 5. To perform the Vendor audit and its compliance for RM/PM. 6. To prepare Vendor Audit Report and confirm the compliance. 7. To Review and Approve the Approved Vendor List of RM/PM. 8. To Review/Approve Annual vendor audit Planner/Scheduler. 9. To receive the pre-purchase samples through Purchase Team and send it to QC/ARD for further assessment. 10. To review the Pre-purchase analyzed report and take necessary action as applicable. 11. To participate in investigation/QRM related to vendor of RM/PM (wherever required). 12. Follow-up with vendor regarding CAPA (wherever applicable)

Responsible for IPQA, line clearance, preventive maintenance checks, BMR/BPR review, vendor qualification, audit support, QAMS documentation, APQR preparation, and compliance verification across departments. Required Candidate profile M.Sc or M.Pharm or BSc or BPharm 2-3 Years 2.5 to 3.5 LPA

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

As a key member of the team at a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry, your primary responsibilities will include leading R&D CRO projects for global customers. You will be tasked with developing non-infringing routes for APIs with sustainable processes, focusing on Impurity synthesis. Additionally, you will play a crucial role in developing robust, scaleable, operationally safe, and commercially viable processes. This includes synthesis route selection, lab feasibility, process optimization, technology transfer, and scale-up & commercialization for tonnage scale campaigns, always prioritizing safety and quality. You will lead a team of R&D scientists, overseeing Process development using the QbD/DoE approach and validations. Your expertise will be instrumental in end-to-end troubleshooting, cost reduction, technology transfer activities, and first-to-file product filings. Furthermore, you will be responsible for the regulatory filing of APIs and addressing any regulatory deficiencies that may arise. In your role, you will ensure that vendor qualification requirements are met for procuring Key Starting Materials (KSMs), reagents, advanced intermediates, and Investigations (OOS & OOT). You will also be involved in CAPA implementation and change controls, necessitating cross-functional engagement with QA, QC, production, and regulatory departments. As the ideal candidate for this position, you will hold a Ph.D. in Chemistry with over 15 years of experience in the CRO / CMS space of process R&D. Your proven track record of excellence and productivity will be demonstrated through your experience in Organic Process R&D in CRO/CMO, particularly in Early and Late Phase NCEs. Proficiency in utilizing a range of laboratory instruments, purification techniques, and Process Analytical Technology (PAT) tools such as NMR, Microwave reactor, flash, RP-HPLC, FTIR, and FBRM will be essential. Additionally, your ability to interpret Design of Experiments (DoE) experimental data using tools like Design Expert & Minitab will be highly valued. Working knowledge of chemical databases like Scifinder, Reaxys, Chemdraw, and MNova will also be advantageous. If you are seeking a challenging opportunity in the pharmaceutical industry and are looking to be compensated in the range of 25-30 LPA annually, we encourage you to apply for this exciting role. For further information or to express interest in this position, please reach out to Anoop Sinha, CEO at PROFILE HR CONSULTANTS PVT LTD, at 9773520069.,

As a Senior QA Officer, your role will involve various responsibilities to ensure quality assurance within the API pharma industry. You will be tasked with issuing Batch Manufacturing Records, equipment cleaning records, logbooks, and analytical reports for raw materials, finished products, and packing materials. Additionally, you will assist in the preparation of SOPs for different departments and conduct plant rounds to verify documents according to cGMP and GLP norms. Line clearance activities for manufacturing and packaging, issuing deviation forms, change control forms, and handling customer complaints will also be part of your duties. You will review and verify analytical and Batch Manufacturing Records, participate in audits and inspections, and ensure data integrity as per procedures. Maintaining documents and records, controlling SOPs and departmental documents, and preparing for internal and customer audits are crucial aspects of the role. You will also oversee activities related to manufacturing, store, and QC, as well as prepare vendor lists, conduct traceability activities, and manage CAPA logs. Ensuring compliance with equipment maintenance, calibration, and training on cGMP and GLP will be essential. Investigating deviations, product complaints, and environmental incidents, as well as conducting process validation and equipment qualification, will also fall under your responsibilities. Your role will involve preparing annual product reviews, handling waste disposal procedures, and supporting environmental management initiatives within the department. Additionally, any other assignments or tasks allocated by the Head of QA will be expected from you. If you are interested in this position or have a suitable reference, please contact Jyoti at 8657017223. This is a full-time job with day shift hours, based in Ankleshwar.,

Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on requirements. Conducting onsite vendor audits with respect to ISO 9001:2015, ISO27001:2022 or other applicable ISO standards. Assessing the potency of vendors for iVRS service. Issuing audit observations, verification of CAPA and issuance of certificates. Verifying the surveillance audit due dates and initiating the surveillance audits within timeline. Score card updates for vendors. Internal Audit: Conducting Internal audit as per iVRS internal audit SOP, Ensuring the compliance with respect to internal SOPs, regulatory guidelines, etc Issuing the audit reports, verification of CAPA, closing the Audits. MRM: Facilitating the MRM upon completion of Internal audit under MR supervision Requesting cross functional inputs Making the MRM presentation Analytical Development: Develop documentation and system as per Quality Management System and ensure its implementation in the laboratory. Preparation of manuals and policies. To review the Manuals, Standard Operating Procedures, and other quality documents and approval of the same. Review and Approval of study protocols, Validation protocols, Qualification protocols and CSV protocols Review and approval of Validation reports, Qualification reports and CSV execution and reports. Develop, implement, and manage processes to ensure that studies / project activities meet required specifications for quality, function, and reliability prior to submission of data to the sponsor/customer. Review and approve of project / study documents related to analytical department to ensure its compliance with inhouse SOPs, study specific protocols, and applicable regulatory requirements & guidelines. Monitoring and ensure that the lab is following practices/ procedures laid down by way of regular planned and unplanned audits. Customer query- to register the query received from customer and handling the investigations Review, monitoring and data compilation of customer queries. Implementing, maintaining and improving the established analytical lab and in-process processes and methods. Verifying and approving the Laboratory incidents and investigations To oversee the activities with respect to Quality Management Systems and Learning and Development. Verification and approval of calibration documents. Verification of Audit trials in various instruments for validation, study and calibrations. Verification of biannual audit trails Attending all mandatory trainings (as applicable) without fail. Clinical Development: Conduct inspections or test checks to determine if all studies are conducted in accordance with the Principles of Good Clinical Practice Review of protocol and other study related documents Site visits whenever required. QMS: Verification of Procedures for its adequacy, To review and approve master list of SOPs. (as a backup to the designated employee) Preparation of new procedures and revision of existing procedures. Preparation, review, approval of Quality assurance procedures. Review and approval of cross function procedures. Verification, authorization/approval/Closure of Change controls, LIR and other QMS forms. Verification and approval of QMS trending. Review IQ, OQ, PQ records, Calibration certificates and Computer System Validation for Automated Software, as per 21 CFR Part 11 compliance. Ensure to follow and accomplish the Quality Objectives and ISMS objectives. Preparation / Verification of QA and ISMS objectives and actuals, Actuals, Risk assessments, Asset lists, etc Training: Ensuring the annual training schedule. Ensuring the mandatory trainings are conducted as per schedule. Ensuring the identified trainings are conducted for team members. Planning regulatory and QA trainings. Conducting BCP-DRT meetings. Ensuring the surveillance audits and ensuring the internal feedbacks.

Role & responsibilities 1)Source and procure APIs and excipient for customer project, ensuring timely delivery of raw material to meet project deadline for site transfer project 2)oversee the arrangement of vendor qualification documents ,manage VQ samples and handle the creation of new vendor codes 3)Coordinate with vendor and legal team doer CDA initiation and closure 4)Coordinate procurement for post launch quantities well in advance ,aligning with the launch schedule and prepare handover sheets containing all necessary details 4)Ensure timely Goods receipt note(GRN)processing 5)Provide support to R&D ,project management and other stakeholders in the development and other stakeholders in the development and filling of customer project 6)Lead negotiations and supply free of cost (FOC)raw materials to R&D for formulation development ,while managing plant purchase 7)Ensure timely payments to suppliers ,maintain strong supplier relationship and financial compliance

Job Title: Manager Quality Assurance (QA) Company: Global Calcium Pvt. Ltd. Location: Unit III – Hosur, Tamil Nadu Experience: 10+ years Qualification: B.Pharm / M.Pharm / M.Sc or equivalent Job Description: We are looking for an experienced Manager – QA to lead our Quality Assurance team at Global Calcium Pvt. Ltd., Unit III (Hosur). Key Responsibilities: Lead Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements. Manage validation and qualification of equipment, utilities, and processes. Ensure audit readiness and compliance with regulatory agencies (USFDA, EU, WHO, MHRA). Review and approve SOPs, protocols, and reports related to validation and qualification. Handle internal audits, external inspections, and CAPA implementation. Guide, mentor, and develop the QA team to strengthen the quality culture. Desired Candidate Profile: 10+ years of experience in QA in the pharmaceutical industry. Strong knowledge of QMS, Validation & Qualification. Excellent communication and leadership skills. Exposure to international regulatory guidelines preferred. Salary: Best in the industry (not a constraint for the right candidate). Industry Type: Pharmaceuticals / API / Bulk Drugs Functional Area: Quality Assurance Employment Type: Full Time, Permanent How to Apply: Interested candidates may share their CV to suganya@globalcalciumpharma.in with the subject line “Application for Manager – QA” .

Designation - Sr. Executive / Asst. Manager - Quality Assurance Company - Leading Pharma Raw Material Mfg. Company Job Location - Ahmedabad Qualification - B.Sc. / M.Sc. / B.E.- Chemical / B.Pharm Experience - Min. 6+yrs. and above Required Candidate profile Company coming up with Greenfield Project Responsible for handling QA / GMP Related documentation QMS, Audit Preparation, Vendor Questionnaire, Market Compliant & Customer Compliance

1. QA Executive Junior Level Experience Required: 24 years Salary Offered: 20,000 per month Job Summary: We are seeking motivated QA Executives with 24 years of experience to support daily quality assurance activities in a GMP-regulated pharmaceutical facility. The role will focus on documentation review, QA activities, and ensuring compliance with regulatory standards. Key Responsibilities: Review batch manufacturing and packing records Line clearance for production and packaging activities Support in handling deviations, change controls, CAPA, and incident reports Ensure compliance with cGMP and Revised Schedule M requirements Participate in in-process checks and quality monitoring Assist in preparation and review of SOPs, logbooks, and other controlled documents Support internal audits and regulatory inspection readiness Qualifications: B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences/Chemistry) 24 years of experience in QA in a pharmaceutical company Good understanding of cGMP and QMS principles Strong documentation and communication skills 2. QA Executive Mid-Level Experience Required: 48 years Salary Offered: 30,000 per month Job Summary: We are looking for experienced QA Executives with 48 years of experience to take responsibility for advanced QA functions, including compliance management, documentation oversight, and training of junior QA staff. Key Responsibilities: Review and approval of batch records, logbooks, and controlled documents Oversee line clearance, in-process checks, and QA compliance Lead and investigate deviations, OOS, OOT, change controls, and CAPA Coordinate with production, QC, and engineering for quality compliance Handle document control, issuance, archival, and retrieval systems Support vendor qualification and raw material quality compliance Prepare for and participate in internal audits and regulatory inspections Mentor and guide junior QA team members Qualifications: B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences/Chemistry) 48 years of QA experience in a pharmaceutical manufacturing unit Strong knowledge of QMS, regulatory compliance, and cGMP Experience in facing audits (USFDA/WHO/other regulatory bodies is an advantage) Excellent analytical, communication, and leadership skills Show more Show less

Specific Responsibility, but not limit to : To review and approval of all concerned department master SOPs / GTP / BMR / Spec. & STP of Finished Products, Raw Materials & Packing Materials and its compliance in the System. Implementation and compliance of approved SOPs in the system To ensure quality system are maintain as per ISO requirements and followed by GMP guidelines. To investigate the route cause for Out of specification analytical reports. To handle the market complaint and investigate to find out route cause and in coordination with concerned departments and communicate to management and customer. To review all critical Deviation are investigated and resolved. Review and approval of Change Control. Review and approval of all Validation and Qualification related activities. Review and approval of Vendor Qualification for supplying of Raw Materials / Packing Materials. Review and approval of Batch records and release of finished product. Conduct Internal and External Audit in coordination with all concerned departments Head. Performing Annual Product Quality review. Conducting and organizing of GMP and on-job training.

As a Process R&D Scientist in the Organic Chemistry field, your main responsibility will be to develop, optimize, and execute processes for APIs to ensure timely implementation within budget constraints. You will need to conduct a literature survey and route selection for assigned projects, prepare and execute development strategies, and maintain records of experiments carried out in the lab. Your role will involve optimizing process parameters to achieve robustness and support the creation of new IP assets by performing experiments related to innovations such as new processes and polymorphs. Additionally, you will be responsible for preparing development reports and tech transfer documents based on the work carried out in the lab, coordinating with manufacturing units for pilot and validation batches, and conducting studies to achieve regulatory compliance. Vendor qualification for key raw materials, compliance with stage gate and milestone meetings checklist, and addressing challenges such as delays in analytical results and re-conducting experiments are also part of your key accountabilities. Your interactions will primarily be with manufacturing, SCM, ADL, QA, QC, IP, ROC, safety, and engineering teams as well as vendors and suppliers. The dimensions of your role include process development for multiple projects and execution of processes on the plant for specific projects. Key decisions you will need to make include the use of specific reagents, solvents, reaction conditions, route selection for development, and selection of vendors for raw materials, instruments, and equipment. To qualify for this role, you should have an M.Sc. in Organic Chemistry and possess 3-5 years of relevant work experience in process R&D.,

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors. We have a presence in over 65 countries with our dynamic team of over 7,000 across generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase, MVI and more. Join USV and be part of our journey as we continue to innovate, transform lives, and shape the future of healthcare. Job Title: Manager / Sr. Manager (Quality Assurance) - API Only Designation - Manager / Sr. Manager - CQA - API Direct Reportees: No Location: HO @ Govandi, Mumbai Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working (sometimes 2-3 days in a month to sites depends on work) Job Responsibilities: Must have audit handling experience for regulatory agencies audits like USFDA, EMA, ANIVSA, CDSCO etc Must have technical knowledge and well versed with regulatory & cGMP requirements Monitoring and Assessment of Quality Management System (QMS) for manufacturing sites and R&D functions. Hands on experience in industry software like TWD, SAP HANA, LIMS, DMS etc., Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc. - QMS Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. Preparation/Revision of CQA SOPs and making master, effective after completion of training. Review of Master formula and technology transfer documents for API sites. To provide training of SOPs, cGMP, or other modules as per the requirement. Review of SOPs related to various departments. Scheduling and participation in self-audits (Sites and corporate functions). Regulatory and customer audit support to sites. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. Participation in Quality related meetings. Education: Min. Qualification Required - B.Pharm./M.Pharm/M.Sc. Experience: Minimum 13-17 years

You will be responsible for coordinating activities related to the preparation of material, dimensions, and purchase specifications of items in compliance with piping standards and job requirements. This includes vendor qualification, evaluation, and finalization. Your role will involve ensuring that all materials meet the necessary standards and specifications required for the project. Your attention to detail and ability to coordinate various tasks will be essential in successfully fulfilling this role.,

Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA closure of the same before the product release. Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities within the due date. Coordinating for complaint investigation, handling of Return Goods and Recall. Review of contract manufacturing / testing documents such as, executed BPR and Analytical reports. Shall be responsible for performing unplanned audit on shop floor. Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident. Shall be responsible for review and closure of Change control and related action items. Shall be responsible for a rchival of change control and other related documents. Preparation of Quality Assurance SOPs and review of plant SOPs. Handling of change control & deviations related to warehouse & SCM. Preparation and Review of Risk Assessment report for New Products & process change products. Shall be responsible to preparation of risk assessment and declaration as per customer requirement and current guideline. Review of Vendor Qualification documents as per checklist and communication to Vendors/Supply Chain Management. Preparation of Vendor audit schedule on annual basis and implementation of schedule as per the frequency defined. To follow and maintain formats and Annexures as per current version of SOP# QAD-SOP-0014, QAD-SOP-0054, QAD-SOP-0081, QAD-SOP-0100, QAD-SOP-0019. Periodic updation of Approved Vendor list as per SOP. Shall be responsible for preparation and review of Annual Product Quality Report (APQR) Periodic Product Quality Report (PPQR) for all the products as per SOP / schedule. Shall be responsible for preparation and review of Product Quality metrics for the products manufactured at the site. Shall be responsible for review of process validation protocol and report. Shall be responsible for preparation and review of cleaning validation protocol and report. Shall be responsible for work assigned by reporting Manager. In the absence of the position holder operational responsibilities delegated to Direct reports or designee. Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA closure of the same before the product release. Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities within the due date. Coordinating for complaint investigation, handling of Return Goods and Recall. Review of contract manufacturing / testing documents such as, executed BPR and Analytical reports. Shall be responsible for performing unplanned audit on shop floor. Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident. Shall be responsible for review and closure of Change control and related action items. Shall be responsible for a rchival of change control and other related documents. Preparation of Quality Assurance SOPs and review of plant SOPs. Handling of change control & deviations related to warehouse & SCM. Preparation and Review of Risk Assessment report for New Products & process change products. Shall be responsible to preparation of risk assessment and declaration as per customer requirement and current guideline. Review of Vendor Qualification documents as per checklist and communication to Vendors/Supply Chain Management. Preparation of Vendor audit schedule on annual basis and implementation of schedule as per the frequency defined. To follow and maintain formats and Annexures as per current version of SOP# QAD-SOP-0014, QAD-SOP-0054, QAD-SOP-0081, QAD-SOP-0100, QAD-SOP-0019. Periodic updation of Approved Vendor list as per SOP. Shall be responsible for preparation and review of Annual Product Quality Report (APQR) Periodic Product Quality Report (PPQR) for all the products as per SOP / schedule. Shall be responsible for preparation and review of Product Quality metrics for the products manufactured at the site. Shall be responsible for review of process validation protocol and report. Shall be responsible for preparation and review of cleaning validation protocol and report. Shall be responsible for work assigned by reporting Manager. In the absence of the position holder operational responsibilities delegated to Direct reports or designee. Handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA closure of the same before the product release. Handling of QMS activities in Track Wise system and documents through SAP system, as applicable. Track and complete all the QMS activities within the due date. Coordinating for complaint investigation, handling of Return Goods and Recall. Review of contract manufacturing / testing documents such as, executed BPR and Analytical reports. Shall be responsible for performing unplanned audit on shop floor. Monitoring of Manufacturing Process to identify the root cause for product failure and cleaning incident. Shall be responsible for review and closure of Change control and related action items. Shall be responsible for a rchival of change control and other related documents. Preparation of Quality Assurance SOPs and review of plant SOPs. Handling of change control & deviations related to warehouse & SCM. Preparation and Review of Risk Assessment report for New Products & process change products. Shall be responsible to preparation of risk assessment and declaration as per customer requirement and current guideline. Review of Vendor Qualification documents as per checklist and communication to Vendors/Supply Chain Management. Preparation of Vendor audit schedule on annual basis and implementation of schedule as per the frequency defined. To follow and maintain formats and Annexures as per current version of SOP# QAD-SOP-0014, QAD-SOP-0054, QAD-SOP-0081, QAD-SOP-0100, QAD-SOP-0019. Periodic updation of Approved Vendor list as per SOP. Shall be responsible for preparation and review of Annual Product Quality Report (APQR) Periodic Product Quality Report (PPQR) for all the products as per SOP / schedule. Shall be responsible for preparation and review of Product Quality metrics for the products manufactured at the site. Shall be responsible for review of process validation protocol and report. Shall be responsible for preparation and review of cleaning validation protocol and report. Shall be responsible for work assigned by reporting Manager. In the absence of the position holder operational responsibilities delegated to Direct reports or designee. Show more Show less

Handle quality complaints, aberrations & compliance, Perform RA, RCA, CAPA, Review &approve deviation, batch record, change control, CAPA, SOP, QMS documents, test method, sampling, Vendor Mgt, dispatch, Approve & review validation/qualficn protocols Required Candidate profile M.Sc.(Chem/Pharma) with 4 to 6 yrs exp in API industry. Knowledge of quality systems, legal documentation & Compliance, instrument handling & calibration, Instruments , Root Cause Analysis Techniques

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

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

Role & responsibilities Overseeing and Co-ordination for vendor qualification (Review and Approval) and performing vendor audits. Review of vendor questionnaires. Handling Vendor queries /complaints. Overseeing and Co-ordination for vendor qualification (Review and Approval) and performing vendor audits Vendor rating for all raw materials. Co-ordination for ROS comparison for alternate vendor development . Review of vendor questionnaires Performing risk assessment for vendor audits Yearly ,Vendor audit plan Review of development reports and evaluation of the process development in case of new products. Review of User trial and LDR report Review of Nitrosmaine and GTA reports from vendors Vendor list updation quarterly Providing the KSM /Intermediate documents to Regulatory department Handling Vendor queries /complaints Preferred candidate profile Candidate must have exposure in QA- vendor management ( API Industry ).

We are seeking skilled and dedicated individuals to join our Quality Assurance (QA) department at Fido Pharma Private Limited, an esteemed pharmaceutical company located at Plot No: 108-109, Global Industrial Park, Mauli, Barwala, Panchkula, Haryana. If you have a background in B.Pharm / M.Pharm / M.Sc. and a passion for ensuring quality in pharmaceutical products, we have the following positions available: QA Manager: As a QA Manager, you will lead our Quality Assurance department, overseeing adherence to GMP and regulatory guidelines such as EU-GMP and WHO-GMP. Your responsibilities will include managing document control, validations, change control, Vendor Qualification, CAPA, deviations, and internal and external audits. You will be the main point of contact with regulatory bodies during inspections, ensuring timely compliance. Additionally, you will be responsible for developing and maintaining the company's quality systems and risk management strategy. Strong knowledge of cGMP, ICH, and regulatory requirements is essential for this role. Excellent communication, team management, and problem-solving skills are required. Previous experience in regulated manufacturing environments is preferred. Assistant Manager - Quality Assurance: In the role of Assistant Manager, you will provide support in managing and executing the site's quality systems, including change control, deviation handling, market complaints, and CAPA monitoring. You will assist in conducting periodic quality reviews and risk assessments and review batch documentation for accuracy and completeness. Internal audits, compliance activities, training sessions, and vendor qualification processes will also be among your responsibilities. A background in B.Pharm / M.Pharm / M.Sc. and 5-10 years of relevant experience are required for this role. Executive - Quality Assurance: As an Executive in the Quality Assurance department, you will be involved in line clearance and in-process quality assurance activities. Your duties will include maintaining documentation, supporting regulatory compliance, conducting internal audits, and assisting in vendor qualification processes. You will also participate in investigations of deviations, training programs, and vendor audits. Reviewing executed BMRs/BPRs, process control charts, and release documents will be part of your daily tasks. A background in B.Pharm / M.Pharm / M.Sc. and at least 1-6 years of experience are necessary for this role. If you are detail-oriented, proactive, and passionate about ensuring quality standards in the pharmaceutical industry, we invite you to apply for one of these exciting positions at Fido Pharma Private Limited. Join our team and contribute to the continual improvement of our quality systems and processes.,

As a Battery Pack Design Engineer based in Bangalore, you will be an integral part of the battery pack engineering team, focusing on addressing complex structural, electrical, and thermal challenges. Your primary responsibility will involve designing and developing components and assemblies for production, testing, POC, and ensuring the safety of highly integrated batteries. Your work will have a significant impact on the product direction, pushing Pravaig to become a leader in battery technology. Your key responsibilities will include: - Demonstrating expertise in structural, electrical, thermal, and mechanical battery systems. - Utilizing strong analytical and problem-solving skills for mechanical engineering analysis. - Leading battery design and development projects, with a preference for 3-D CAD experience. - Familiarity with sensor instrumentation and data acquisition systems is advantageous. - Analyzing and managing test data from large data sets. - Applying knowledge of statistical analysis and design-of-experiment techniques. - Possessing excellent written, verbal, and presentation skills to effectively communicate with management, peers, and suppliers. - Adapting to a dynamic and fast-paced work environment. - Conducting vendor qualification for manufacturing processes. - Expertise in designing for various production processes such as injection molding, extrusion, metal stamping, die castings, sheet metal, and weldments. - Ensuring the preparation and release of all 3D data, drawings, and part specifications. Required Skills: - Strong problem-solving and analytical skills with knowledge in battery cell design and material characterizations. - Taking ownership of Battery Pack components, overseeing engineering development from concept to production. - Integrating mechanical designs with high voltage electrical systems within a multidisciplinary environment. - Proficiency in DFM, DFMEA, PFMEA, and DFA methodologies. - Ability to interpret engineering/manufacturing drawings and good knowledge of GD & T. - Familiarity with various materials used for Battery Packaging & Electric Vehicles. - Results-oriented with proven creative and critical thinking abilities. - Maintaining flexibility and composure in ambiguous and rapidly evolving situations. - Awareness of engineering standards and automotive regulations. - Comfortable with initiating and leading projects.,

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.

Regulatory Affairs associate with knowledge in Indian Market. Customer & Regulatory communication and responses, Vendor qualification, Tracking of changes, Preparation of DMF's, Regulatory Affairs with knowledge in Indian Market. Required Candidate profile Candidates from Pharma background only with experience in Regulatory Affairs on Indian Market.