43 Vendor Qualification Jobs - Page 2

Immediate joiners are preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com 1.To review and implement Quality Management System for cGMP compliance at site. 2.To review and approve of product design. 3.To review and approval of production and quality control documentation for compliance with GMP and GLP requirements. 4.To Handle Caliber BRM, QAMS, DMS, Nichelon 5 CMS, E-logbook, E-schedule, Microsoft Dynamic, NCR 5.To review and approve SOPs, Validation Protocols, Master Batch Production Records and other related documents at site. 6.To review and approve Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP. 7.Approval signatory for all SOPs, Master Batch Records, Qualification, Validation, documents of Analytical and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations, Stability Protocols, and other Master Documents. 8.Vendor Assessment. 9.Handling of OOS. 10Process validation and equipment cleaning validation. 11.To review batch production Records and Analytical documents, to assure that the batch has been manufactured and tested as per laid down procedure / specification. Deviation if any, are recorded, investigated, documented and authorized. 12.To export certification for batches intended for exports. 13.To release (approval or rejection) the batch manufactured at site. 14.To monitor qualification, validation and requalification activity at site. 15.To trend the data and analyses the trend. 16.To Prepare and approve Annual Product Quality Review for drug substance / drug product quality, Recommend the area of improvement, as applicable. 17. To investigate market compliant. Review response. 18.Handling of product recall. 19.To review Product License Application and support Regulatory department for obtaining the product license from the local Regulatory Authority. 20.To review and submit the data / information to Regulatory Affairs for preparation of DMF/dossiers/application for registration of the product with Regulatory Authority of the countries, intended to market the product. 21.To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit.

Responsibilities: * Conduct BPR reviews, BMR reviews, process validation & cleaning validations. * Ensure compliance with industry standards during equipment & water validations. Accidental insurance Annual bonus Leave encashment Gratuity Provident fund

Roles and Responsibilities Conduct equipment qualification, validation, and vendor qualification activities according to established procedures. Perform process validation protocols, reports preparation, and CAPA implementation as required. Ensure compliance with regulatory requirements by maintaining accurate records of documentation and data analysis. Collaborate with cross-functional teams to identify areas for improvement in validation processes. Develop and execute test plans for new equipment installations or modifications.

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audit Reediness if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com

Roles and Responsibilities Ensure compliance with cGMP guidelines during documentation review, approvals, and vendor qualification. Conduct artwork checking, document preparation, FDCA applications, OOS investigations, and factory coordination. Review documents such as BMR/BPR/SOPs/protocols for quality control purposes. Coordinate with cross-functional teams to ensure smooth operations. Desired Candidate Profile 2-5 years of experience in a similar role within the pharmaceutical industry. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Science (MS/M.Sc). Strong understanding of Good Manufacturing Practices (cGMP), Document Management Systems (DMS), Quality Control procedures.

> Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. > Desired Candidate Profile: Bachelor's or master's degree in engineering, life sciences, or a related field. A minimum of 6 years of experience in quality assurance within the medical device or pharmaceutical industry. Strong knowledge of validation processes, quality systems, and regulatory standards, such as MDD 93/42/EEC and ISO13485. Experience managing CAPA (Corrective and Preventive Action), conducting risk assessments, and handling internal/external audits. Proven ability to manage validation projects, including scheduling and team coordination. Excellent communication, organizational, and analytical skills. > Role & Responsibilities: Plan and execute validation and calibration activities according to the approved schedule, including HVAC, process, transport, sterilization, equipment qualification, and temperature mapping. Coordinate the preparation of PR, PO, material issuance, and service entries for validation-related activities. Provide training to relevant personnel on validation processes and artwork review. Review and compile validation reports from external agencies, ensuring timely approval and payment processing. Verify vendor agreements and certifications, ensuring timely renewals and regulatory compliance. Oversee and ensure the proper execution of QMS activities, including document management and software use (e.g., TrackWise). Participate in line clearance and IPQA (In-Process Quality Assurance) activities as needed. Prepare and review GMP (Good Manufacturing Practice) documents such as SOPs, protocols, and other required documents. Ensure adherence to ISO13485 standards and other relevant regulations. Collaborate with the regulatory department to provide validation and calibration documents as needed for regulatory submissions. Participate in internal and external audits, ensuring timely and accurate documentation submission. Manage PR initiation and closure in TrackWise for qualification and calibration activities. Prepare and execute equipment and utility validation documents as per schedule. > Functional Skills Required: Expertise in Quality Management Systems (QMS) and validation processes. In-depth knowledge of MDR and other relevant regulatory frameworks. Strong proficiency in CAPA management, auditing, and risk assessment. Technical expertise in process, equipment, and product validation. Ability to manage multiple validation projects and meet strict deadlines. > Behavioral Skills Required: Strong team management and leadership abilities. Excellent problem-solving and analytical skills. High attention to detail and a commitment to accuracy. Strong interpersonal and communication skills. Ability to collaborate effectively across teams and departments. A proactive approach to continuous improvement and maintaining high-quality standards. > Team Size to be Handle: Manage the team of 2-3 team members of Validation & QMS, reporting to AGM-QA. Learn more at https://www.biotechhealthcare.com. Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

Role & responsibilities JD- Designation: Deputy manager Department: QA Role: vendor qualification Experience:6-10 years of relevant experience. 1)Preparation and Review of procedures related to Vendor management as per regulatory requirements. 2. Review of QMS elements like Change management (Change control), Deviation, CAPA, related to external testing laboratories, service providers. 4. Management of vendor qualification (Related to Contract services/ contract Labs /CMO) documentation i.e. initiation of vendor assessment, tracking of their audit and periodic monitoring. 5. Responsible for vendor Audit Schedule, Execution of site audit for Contract Testing Laboratories, Contract Service Providers. 6. Preparation of Vendor audit reports, reviewing Audit CAPA reports, regular Follow-up to vendor for closure of Audit Observations. 7. Updating of Approved vendor list. 8. Handling of Quality Agreements/CDA with Vendors (Contract Testing Laboratories, Contract Service Providers) 10. Preparation of annual periodic verification of Vendors. Preferred candidate profile

Role & responsibilities Lead the vendor qualification process, including the evaluation and approval of new and existing vendors. Review and approve vendor documentation to ensure compliance with internal standards and regulatory requirements. Manage QMS notifications, ensuring timely resolution of issues related to change control, deviations, and CAPA. Oversee the preparation, review, and approval of SOPs to ensure alignment with current practices and regulatory standards. Conduct comprehensive risk assessments and risk analysis to identify potential quality issues and implement mitigation strategies. Independently plan, conduct, and report on vendor audits, coordinating with internal and external stakeholders to schedule and execute audits. Preferred candidate profile Bachelors or Masters degree in Pharmacy from a reputed institution. Should have 10 -15 years in corporate quality assurance roles within the pharmaceutical, biotechnology, or related industries. Should be proficient in quality management software such as Trackwise, Caliber, SAP, TMS, DMS, and QAMS. Should have experience in vendor qualification management, vendor documentation and managing vendor audits.

Quality Management System: Oversight/Handling of Handling of Change Control, Incident / Deviation and CAPA. Following and tracking of Change Control, Incident /Deviation and CAPA. Involved in the investigation activity whenever required. Ensure that products are manufactured in compliance to Regulatory requirements and as per Good Manufacturing Practices. Ensure that production and manufacturing activities are undertaken in compliance to SOPs, systems, procedure and GMP/GLP requirements. Maintain GMP compliance in various departments to manage the production in line with the current GMP requirement. Handling of Change Control, Deviation, risk assessment and CAPA as per company procedure Verification & Follow-up of CAPA implementation as per provided target completion date. Involved in the handling of Market Complaints. Review of QMS documents. Vendor Qualification Activity: Oversight of Vendor Qualification related documentation. Planning and execution of the vendor Qualification activity with co-ordination with user department. Preparation and review of document related to Vendor Qualification. Execution of schedule / planned Vendor/Supplier Qualification as per the Protocol. Qualification/ Validation - Data compilation and Report preparation. Review and compilation of data generated in validation and qualification of vendors. Coordination with external agency for Qualification, validation, calibration and outside services related to Vendor Qualification. Qualification of External agency for Qualification, Validation and Calibration agency as per the SOP. Planning of the vendor audit as per requirement. Self-Inspection: Oversight of Self-Inspection program 4. Management and overall tracking of audit observation- Audit & Compliance (Internal and External audit). Oversight of IPQC & Microbiology Section: - Ensure in-process product and process related quality assurance activities (IPQA) are undertaken by IPQC team. Validation and Qualification Activity: Review of Validation and qualification related activities as and when required. Planning of the validation activity with co-ordination with user department.

Management of the Technical document needed for the specific grade of the product Knowledge of material qualification and certification part 2-5 years of experience in pharmaceutical, API or excipient regulated industries

HIRING! We are Hiring for Quality Assurance Department with OSD Background: QUALITY ASSURANCE Open Positions: Officer/Sr. Officer - 2 to 7 years Desire Profile : 1. Hands on experience of review of batch record and COA. 2. Well-versed in schedule M and others regulatory guidelines. 3. Knowledge of export documentations. 4. Exposure of handling regulatory and customer Audits. Interested candidates may share updated resume at hr.plant@zuventus.com

QA Senior Executive / Quality Assurance Manager CTC UPTO 6 LPA, Contact: 09990842892 Email: info@wellgen.in We are a 30-year-old Medicine Manufacturer Company is located in Baddi Experience : Minimum 7 years of Pharmaceutical Experience Qualification : B.Pharm You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)Role & responsibilities Preferred candidate profile Male candidate

Roles and Responsibilities (Hiring for AQA Role, IPQA Role, QMS Role - API Background is Must) Ensure compliance with GMP, BMR, BPR, SOPs, and quality systems. To Perform Analytical QA Role IPQA Activities QMS Activities Validation Activities Collaborate with cross-functional teams to ensure timely completion tasks Person Should be from the API Background

We seek a meticulous Quality Engineer to champion quality excellence in our expanding renewable energy projects at Solon India Pvt Ltd. As a Quality Engineer, you will play a crucial role in ensuring the planning, procurement, installation, and commissioning phases of our solar power projects meet the highest quality benchmarks. Your responsibilities will include developing and implementing QA/QC plans, conducting rigorous inspections of incoming materials and site installations, and maintaining comprehensive Quality Documentation. You will collaborate closely with cross-functional teams, including procurement, design, and site execution, to enforce compliance with ISO 9001, IEC, IS, and other relevant industry standards. Identifying and addressing recurring quality issues through root cause analysis and Corrective and Preventive Actions (CAPA) will be key to your success. The role also involves supporting Vendor Qualification, internal and external audits, and driving continuous improvements to enhance project quality and reliability. You will also be responsible for implementing SOPs and Standard Templates and can suggest improvements. If you are passionate about sustainable energy and committed to delivering reliable and efficient solar power systems, we encourage you to apply and contribute to our mission of powering a greener future. Job Details: Industry: Renewable Energy Department: Quality Assurance/Quality Control Role: Quality Engineer Location: Hyderabad Compensation: 3-7 LPA Experience: 1-4 years Employment Type: Full-time Qualification: Bachelor's/ Master's degree in Electrical/Mechanical Engineering or related field Responsibilities: Quality Planning and Documentation Develop, implement, and maintain project-specific Quality Assurance and Quality Control (QA/QC) plans in alignment with project requirements and industry best practices. Maintain comprehensive Quality Documentation, including checklists, Inspection Test Plans (ITPs), Non-Conformance Reports (NCRs), and calibration records. Ensure all quality records are meticulously maintained, readily accessible, and traceable throughout the Engineering, Procurement, and Construction (EPC) lifecycle. Implement and improve Standard Operating Procedures (SOPs) and standard templates to streamline quality processes and ensure consistency across projects. Inspection and Testing Conduct thorough Incoming Material Inspection for critical components such as modules, inverters, structures, and cables to verify compliance with specifications and quality standards. Oversee and monitor civil and electrical work at project sites to ensure workmanship aligns with design specifications, industry codes, and established quality benchmarks. Perform random checks and audits at various project stages, including civil foundation, structure erection, module mounting, and cabling, to identify and address potential quality issues proactively. Coordinate and supervise third-party inspections and testing activities to ensure objective assessment and validation of project quality. Ensure all inspection and testing equipment is properly calibrated and maintained to ensure accurate and reliable results. Document all inspection and testing results meticulously and communicate findings to relevant stakeholders promptly. Compliance and Standards Ensure strict compliance with ISO 9001, IEC, IS, and other applicable industry standards and regulatory requirements throughout the project lifecycle. Liaise with vendors and contractors to enforce adherence to established quality benchmarks, specifications, and contractual obligations. Support internal and external audits, certifications, and regulatory inspections by providing necessary documentation, data, and support. Monitor and track changes in industry standards and regulations to ensure project compliance and alignment with evolving requirements. Develop and improve corrective action plans to address non-compliance issues identified during audits or inspections. Maintain up-to-date knowledge of relevant standards and regulations and provide guidance to project teams on compliance requirements. Problem Solving and Continuous Improvement Conduct thorough root cause analysis of defects, failures, or non-conformances to identify underlying causes and implement effective Corrective and Preventive Actions (CAPA). Identify recurring quality issues and recommend process improvements, procedural enhancements, and training initiatives to prevent future occurrences. Work collaboratively with procurement, design, and site execution teams to enhance project quality through proactive problem-solving and continuous improvement efforts. Track and monitor the effectiveness of corrective actions and preventive measures to ensure sustained improvement in project quality. Participate in regular quality review meetings to discuss project performance, identify areas for improvement, and share best practices. Promote a culture of continuous improvement and quality excellence throughout the organization by encouraging employee involvement and feedback. Vendor Qualification and Management Develop and improve the Vendor Qualification process to assess and select suppliers based on their ability to meet quality requirements and project specifications. Conduct regular audits of vendor facilities and processes to ensure compliance with quality standards and contractual obligations. Collaborate with procurement teams to negotiate quality agreements and performance metrics with key vendors. Monitor vendor performance and address any quality issues or non-conformances promptly. Provide technical support and guidance to vendors to improve their quality processes and capabilities. Maintain a database of qualified vendors and track their performance over time. General Expectations and Past Experiences: Possess 1-5 years of experience in QA/QC roles within solar EPC, renewable energy, or infrastructure projects. Demonstrate a strong understanding of solar power systems, components, and the project execution lifecycle. Exhibit in-depth knowledge of QA/QC procedures, ISO standards, and industry codes (IEC, IS). Proficient in Incoming Material Inspection, Site Inspections, and Compliance Management. Experienced in the Development of SOPs and Standard Templates. Capable of conducting Root Cause Analysis and implementing Corrective and Preventive Actions (CAPA). Skilled in utilizing Document Management Systems (DMS) and applying Sound Quality Control principles.

Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Assurance Executive & Sr.Executive injectables&OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1.IPQA 2.QMS 3.AQA 4.Validation 5.Equipment Qualification 6.CSV 7.Market Complaints. The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in or feel free to call on 6305391924 Thanks and Regards Prasanthi - Dashboards Team HR

Role & responsibilities Department: Quality Assurance Skill set: 1)QA- stability & Retain sample 2) Doc cell 3) QA Regulatory Designation: Officer/ Sr. Officer/ Executive/ Sr. Executive Education: M.Sc / B.Pahrma / M.Pharma Experience: 2 to 10 Department: OSD Packing Skill set: Operate and monitor primary packing machines such as blister packing, strip packing, and bottle packing machines.,Perform in-process checks like weight variation, visual inspection, and seal integrity. Designation: Officer/Executive Education: B.Pahrm/Diploma/ITI Experience: 2 to 10 years Department: CQA Skill set: 1) Doc Team (Candidates from QC background with LIMS handling experience can apply) 2) CQA compliance + Doc cell 3) Vendor management + Artwork 4) Loan license/ Third party Designation: Officer/ Sr. officer/ Executive/ Sr. Executive/ Assistant manager/ Manager Education: B.Pharma/M.Pharma/M.sc Experience: 2 to 16 years

To prepare and review vendor qualification SOP, Contract Service Provider and Contract Manufacturing in line with current regulatory requirements To review and compilation of vendor qualification documents & to carry out Vendor Qualification/ Requalification, Service provider Qualification/ Requalification activity and Contract Manufacturer Qualification/Requalification activity. To perform risk assessment, performance evaluation of vendors, handling of change notifications. Handling of Vendor complaint management system. To maintain QM Info record in SAP & to block the materials in SAP. Updating & maintaining the Vendor list, Technical Agreements for Raw material, Packing material, Service provider and contract manufacturers. Responsible for Vendor Audit and Compliance of Vendors for Key Starting Materials, Advance Intermediates, APIs, Excipients, Primary Packaging Material, Secondary Printed Packaging Material, Contract Service Providers and Third Party Manufacturing Sites To prepare and review system related SOPs and other CQA SOPs/ documents respectively. To handle Customer/ Regulatory Audits relevant to vendor qualification activity. To review, approval of quality management documents i.e. change control. Deviation, Risk Assessment relevant to vendor qualification activity.