271 Process Validation Jobs - Page 6

Line Clearance for production start & after maintenance work,In-process product check daily check for in-process material,Pre-Operation findings,Weekly monitoring of Glasses, Hard &Brittle plastic and Wood.Deviation & Non confirming product & process Required Candidate profile Process Improvement & Optimization,Audit & Inspection,Managed daily IPQA activities, batch record reviews and deviation investigations,Collaborate with production and R&D teams resolve quality issues

- This role is responsible for overseeing the operations of a specific block within the manufacturing facility, ensuring efficient production processes, compliance with quality and safety standards, and meeting production targets. To meet the production targets To ensure the implementation of current Good Manufacturing Practices and SOPs at work place To maintain and improve the product quality as per standard To ensure Accuracy, Reliability, validity, integrity and completeness of the cGxP data/records To plan the department activities as per weekly delivery schedule for OSD and Liquid orals To ensure the effective control on man, machine and material in the department To participate and coordinate various on-going qualification and validation activities Collaborate with the site quality head, QA & QC head in ensuring that the production is aligned to the quality standards and regulatory requirements To ensure the completeness of all the trainings (Sops, Technical, Developmental and Regulatory etc.) assigned to block personnel s To organize and implement the on-job training activities in the department To ensure the implementation of EHS practices during work To ensure the maintenance of equipment and upkeep of department constantly To control the rejection during manufacturing and packing operations To do counseling and grievance handling of the subordinates To prepare, review and approve the Standard Operating Procedures To evaluate deviations, change controls and other quality documents for appropriate conclusion To ensure the market compliant investigations as per the track wise module and its timely closure and awareness training to all the concerned persons Handling of QMS related activities of Block To carry out the batch failure investigation for root cause identification and accordingly appropriate corrective action and preventive action taken To review and approve the equipment qualification protocols, process validation protocols, reports, specifications and master formulae Job Requirements Educational Qualification M.Sc. /B Pharma / M.Pharm Experience Tenure : 18-20 years Disclaimer:

JOB DUTIES AND RESPONSIBILITIES (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processes. 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Required Candidate profile Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility Pls mention this Feel free to reach me email Visit our website for more details: Follow Capital Placement Services Linkdein Profile for more updates :

Job Duties and Responsibilities (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processe 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 10 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 11 Assist with complaint investigations for internally produced commercial product 12 Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable). 13 Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules

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 Pharma/ M Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system Show more Show less

The Senior Executive QA (Vendor Management) will be responsible for managing vendor qualification processes, preparing periodic vendor audit schedules, and ensuring vendor compliance in line with cGMP and global regulatory expectations. The role also involves reviewing and maintaining Quality Agreements, monitoring vendor performance, supporting cross-functional risk assessments, and ensuring timely closure of audit observations. The position demands strong coordination with cross-functional teams, external vendors, and regulatory bodies. Key Responsibilities: Execution and oversight of vendor qualifications Planning and coordination of vendor audits Preparation and review of Quality Agreements with external partners Risk assessments and periodic performance reviews of critical vendors Handling of audit observations and CAPA follow-up Supporting change control and deviation management related to vendors Qualifications B.Pharm / M.Pharm / M.Sc. in a relevant discipline 5-8 years of relevant experience in Quality Assurance, specifically in Vendor Management Sound knowledge of GMP regulations (USFDA, EU, MHRA, etc.) Experience in vendor audits and supplier qualification Strong documentation, communication, and interpersonal skills Proficiency in QMS tools and audit management systems

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Data Warehouse ETL Testing Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing application features, and ensuring that the applications function seamlessly within the existing infrastructure. You will engage in problem-solving discussions, contribute innovative ideas, and refine application functionalities to enhance user experience and operational efficiency. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Assist in the documentation of application processes and workflows.- Engage in continuous learning to stay updated with industry trends and technologies. Professional & Technical Skills: - Must To Have Skills: Proficiency in Data Warehouse ETL Testing.- Good To Have Skills: Experience with data integration tools and methodologies.- Strong understanding of data quality and validation processes.- Familiarity with database management systems and SQL.- Experience in performance testing and optimization of ETL processes. Additional Information:- The candidate should have minimum 3 years of experience in Data Warehouse ETL Testing.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Webdriver IO Appium Ensure all planning and execution of assigned QA work (Integration, System, End to End and User Acceptance, production support) in ROL and Mobile channels are addressed on time without any escalations. Participate in assigned Scrum ceremonies. Understand QA scope provide QA estimates and plan the tests. Create Test cases scripts (manual and automated) and ensure test data is in place for planned tests. Execute Tests (manual and automated) on time. Conduct ADA testing using JAWS, Voice Over, Talkback Level Access and NVDA Understand existing Automation Framework and support automation testing needs for UI and API Automation. Good communication skills and coordinate with onsite members as needed. Participate in production validation and support as needed. Follow defect management process and support defects triaging Daily status reporting in stand ups and to leadership during Functional Testing or Regression Testing and ensure the release defects are tracked to closure. Risks/Issues within team are communicated proactively to Immediate Manager and assist in tracking them to closure. Be a team player in ROL and Mobile channels and add value to Testing needs. Comply with Huntingtons standards of the Agile Methodology and adhere to testing strategies & procedures within the industry standard. Basic Qualifications Minimum bachelors degree in computers science or similar. 5plus years of handson experience with industry standard testingdevelopment, quality assurance methodologies, verification, and validation processes. 3 years of handson experience in building automation scripts using Selenium, Java, WebDriverIO, Appium, Cucumber for UI Automation 1plus years of handson experience in the following areas Using Jenkins for maintaining the automation runs on daily basis. API Automation using Rest Assured or any other API Automation tool Working experience Agile Methodology as Quality Assurance Automation Developer Analyst Mainframe Database testing Azure Dev Ops for Test Management, Defect Management , Automation repository usage. Any other test management tool also works. Testing on mobile devices Android & iOS and web applications in banking domain preferably payments Preferred Qualifications Flexible to work in a dynamic environment and support QA work in a timely manner. Experience in building automation script using Cucumber or Spec flow. Experience in working on Perfecto Knowledge on Continuous Integration and Continuous deployment

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

Role & responsibilities Preparation, Review and Execution of Process Validation Protocols and summary reports based on the Analytical results and Batch documents data.

Should have in depth knowledge of ISO 9001, ISO14001, & ISO 45001 standards. Certified internal auditor / Lead Auditor will be an added advantage. Proficiency in GD&T and engineering drawing standards. Knowledge about manufacturing processes / work experience in chemical etching process , electroplating , mechanical stamping, furnace operations etc. Should have detailed knowledge on process validation , feasibility study and part qualification methods. Collaborate with CFT to support new part development , process improvement, and risk management. Sound knowledge of risk assessments, PRD, CP, FMEA, and RCA (5 Why, 8D problem solving, Fishbone Diagram, and Pareto Analysis). Ability to perform and interpret tolerance analysis , SPC & measurement system evaluations . Lead a Team of 10-15 quality technicians and 3-5 quality engineers Train and mentor IQC & IPQC teams and promote quality culture and continuous improvement . Documentation – Creating and maintaining quality documentation, standardization and creating and developing quality business processes and systems Monitor quality KPIs , analyse trends, and report findings to the reporting manager. Take appropriate corrective actions on time to prevent recurrence. Responsible for conducting Inhouse QMS & Process Audits periodically as per the schedule. Lead and coordinate internal and external audits (supplier) , ensuring timely closure of non-conformities. Oversee calibration and validation of equipment, including master gauges, ensuring traceability and accuracy. Manage internal / external customer complaints , conduct a detailed root cause analysis , and implement corrective and preventive actions (CAPA) on time. Excellent leadership, communication, and analytical skills. Proficiency in MS office, ERP/MES systems , quality management software, data analysis. Understanding of industry specific regulatory standards and safety requirements (e.g., ISO, CE, UL, RoHS, REACH), is an added advantage. Education and Experience Required : Engineering in Mechanical with minimum 7-10yrs of work experience in Quality assurance is desired. Experience of working in stamping, chemical etching or electroplating industry is preferred. Skills:- 8D Problem Solving, ISO 14001, ISO 45001, ISO 9001, Measurement Systems Analysis (MSA), Production Part Approval Process (PPAP), Quality Assurance (QA), Statistical Process Control (SPC) Education: - Bachelor of Engineering / Bachelor of Technology (B.E./B.Tech) - Mechanical Engineering Ohmium is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Process Validations : You will validate manufacturing processes to ensure they meet quality and efficiency standards. Special Purpose Machines (SPM) : You will be involved in creating specifications, finalizing concepts with cross-functional teams (CFT), and overseeing the installation, commissioning, and validation of SPMs. Low-Cost Automation : You will implement low-cost automation solutions to improve efficiency. Process Layouts : You will design and optimize process layouts for new lines and existing ones. Online Troubleshooting : You will provide on-the-spot troubleshooting for tooling and process-related issues on the production line. Error Proofing : You have experience implementing error-proofing (poka-yoke) techniques to prevent defects. Quality & Documentation You will ensure the highest quality standards are met through rigorous documentation and audit processes: Process FMEA : You have hands-on experience conducting Process Failure Mode and Effects Analysis (PFMEA) . Customer Audits & PPAP : You have experience with customer audits and the Production Part Approval Process (PPAP) . Quality Systems : You have a strong knowledge of quality management systems like IATF and TQM , as well as Industrial Engineering and Line Balancing . Technical & Financial Knowledge You will combine technical skills with an understanding of financial implications: Pneumatics & Hydraulics : You have a strong understanding of these systems. Process Costing : You have both knowledge and hands-on experience related to process costing, ensuring financial viability.

New Product Development. Integrate automation system with exisiting manufacturing equipments and infrastructure. Conduct testing and validation of automation systems to ensure functionality and performance meet requirements. Provide technical support for troubleshooting mechanical issues and implementing corrective actions. Optimize automation process to improve efficiency, reduse waste and minimize downtime. Develop and maintain documentation related to NPD, Including specification, drawings and operating procedures. Collaborate with vendors and suppliers to select and procure FTG, SPM Components & equipments. Management of facilities like equipments & spares, coordinate with maintenance team to improve the quality/productivity. Provide cost saving in direct and indirect material, coordinate with R&D for implementation of cost saving ideas - ECR to EPI, wastage elimination reduction. To ensure safety of operators, workplace, facilities, fatigue reduction/elimination, improvements / SIAT to done. Improve quality by resolving chronic/major issues by process/design change, regular process audit. Preferred candidate profile DME/B.E/B.Tech - Mechanical with 5+ years of experience in manufacturing engineering. System Knowledge: QMS, OSHA, EMS, EnMS Data Management, Process Compliance of ISO standards.

Process Validations : You will be responsible for validating manufacturing processes to ensure they meet quality and efficiency standards. Special Purpose Machines (SPM) : You will be involved in creating specifications for SPMs, finalizing concepts with cross-functional teams (CFT), and overseeing their installation, commissioning, and validation. Low-Cost Automation : You will implement low-cost automation solutions to improve efficiency. Process Layouts : You will be responsible for designing and optimizing process layouts. New Lines Setup : You have hands-on experience setting up new production lines. Online Troubleshooting : You will troubleshoot tooling and process-related issues on the production line. Error Proofing : You have knowledge of and experience with implementing error-proofing techniques. Hydraulics & Pneumatics : You have knowledge of pneumatic and hydraulic systems. Quality & Documentation Process FMEA : You have hands-on experience with Process Failure Mode and Effects Analysis (PFMEA) . Customer Audits : You have experience with customer audits, ensuring processes meet external standards. Customer PPAP : You have experience with Production Part Approval Process (PPAP) , working with customers to approve parts. Quality Systems : You have knowledge of quality management systems like IATF and TQM , as well as Industrial Engineering and Line Balancing . Costing & Financial Knowledge Process Costing : You have knowledge and hands-on experience related to process costing, ensuring financial viability.

Planning & Co-ordinate Internal/ External/Customers Audits. Reviewing Customer audits and non-conformity reports and ensuring corrective actions are effectively implemented. Validation protocols and reports. Reviewing BMR, Analytical Records.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

Nutrizo Advancis Healthcare Private Limited is looking for IPQA-Chemist to join our dynamic team and embark on a rewarding career journey Conduct in-process quality checks during manufacturing Ensure compliance with GMP and SOP standards Document results and report deviations Coordinate with QA and production teams

2 - 8 years experience into analytical compliance, cleaning sampling. RA Coordination, Process validation, QMS

Role & responsibilities: 1. Ensure the data compilation of Analytical Raw Data and its relevant log entries of In-process, Intermediates, Raw Material, Finished products, Hold time study, process validation, cleaning samples, Vendor development. 2. Planning, Monitoring of sampling, analysis and release of raw materials, packing materials and finished goods. 3. Handling of Laboratory incident and assist in the investigation of Out of Specification, Out of calibration and Out of trend results and customer complaints. 4. To coordinate with ADL/R&D for OOS investigation. 5. Responsible for all QMS activities carried out in quality control laboratory and compliance as per existing SOPs, safety and cGLP. 6. Ensuring instruments and equipments calibration as per master schedule and updating of calibration status labels and review of Calibration records. 7. Develop second line leadership within the department as part of succession planning. 8. Co-ordination with Regulatory Affairs and QA department to fulfil their requirements. 9. To keep the facility all time ready for regulatory and customer audits. 10. Initiate, review LIMS error handling & prepare the investigation report. 11. Initiation and review of change control / discrepancy, Specification / STP, Test data sheet. 12. Conducting training related to analytical instrument, Document control systems, Specification / STP. 13. Review, approve the process/ cleaning validation request. 14. Preparation, review and revision of Specification / STP, Test data sheet. 15. Upload the Specification / STP, Test data sheet, SOP, protocol, report into DCS. 16. Co-ordination with QA, DQA, CQA, RA, ADL, CRD departments for revision and approval of Specification / STP, Test data sheet.

Involving in Validation of Batches and Qualifications of equipment's Carryout In process & review of all packing IPQA activity of Tablets, Capsules and soft gel area Calibration of Balance and all IPQC instruments. Ensuring that all Log sheets & Records are updated on-line Issuance and Review of BPR & SOPs with the operation. Line clearance related works before starting of production activity Equipment Qualification

> 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.

Job Receiving user indents, verifying with approved budget, and floating RFQ to the vendor (minimum 2 to 3 vendors). Preparing a worksheet to validate supplier quotes based on cost, quality, OEM, and delivery lead time Knowledge of SAP for PO release. Create PSR and follow the PSR approvals stage-wise. PO release. Monitoring material delivery against committed vendor dates. Coordinating with the maintenance team for installation and commissioning. Coordinating with the logistics team. Coordinating material in warding and acceptance, and vendor payment. Asset management and handling the Audits Generating and circulating reports to management. Relevant Experience: Mechanical and Electrical, Computer, SAP and Microsoft Office. Work Experience Job DME / DEE \u2013 3 - 4 Years of experience in a Projects role. External Interfaces: Follow up with all project-related work with the vendor. Follow-ups with Government officials for approvals for TEAL Unit 2. Follow-ups with suppliers to ensure timely delivery of materials to complete the work on time. Internal Interfaces: Coordinating with all the departments for the user indent and functional requirements. Maintaining the PO, Legal & Statutory documents. Behavioural Skills: Dealing with vendor and get the material on time. Listening and understanding the User / Vendor/ Management/ Functional requirement. Process Contribution: Quality :Execute the Project as per the User and functional requirements of the project. Checking and inspecting the Quality of material as per requirement and TEAL Standard.(Maintain the User / Vendor relationship ) Delivery: On-time Execution of all the Projects without deviation. Performance Measure PMS rocesProcess Contributions Contributioness ContContributionocess Contribution

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

QMS Activities IPQA Activities Validation Activities Must be having experience in API Desired Profile: Designation : Officer / Executive/ Senior Executive Qualification : M.Sc. Chemistry/ B.Pharm/ M.Pharm Experience: 02 10 year