98 Equipment Qualification Jobs - Page 2

Role & responsibilities Analyze U.S. generic market opportunities using IQVIA, FDA databases, Orange Book, and competitive intelligence tools Identify and prioritize products based on market size, competitive landscape, development feasibility, and potential profitability Conduct patent, exclusivity, and litigation analysis (Paragraph IV, FTF opportunities) Work closely with R&D, Regulatory, Legal, and Supply Chain to ensure selected products align with internal capabilities Track product development pipeline and communicate risks or bottlenecks Prepare business cases and forecasting models for executive decision-making Preferred candidate profile: Bachelor's or Masters in Pharmacy, Life Sciences, or related field MBA or PGDM (preferred) 25 years of experience in portfolio management, regulatory affairs, or business analytics in the pharmaceutical industry Strong understanding of U.S. FDA regulatory and legal environment for generics

Job Description Physical verification and readiness of equipment and instrument for process. Arranging the process accessories and consumables in process area before batch execution. Coordination for dispensing of raw material required for the production processes. Preparation of process, equipment and area related SOPs and EOP s. Preparation of process, area and equipment qualification/ validation protocols. Preparation and execution of various reports like process, equipment, area qualification and validation. Request and Issuance of BPR. Preparation and review of BPR. Preparation and execution of study protocols, URS as and when required Work Experience 4 to 7 Years in Downstream processing. Education Masters in Biotechnology or Biochemistry B. Tech in Biotechnology or Biochemistry Competencies

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

1. Planning and preparation of qualification protocols and documents for equipment, instruments, systems, including of utilities, manufacturing process, packing equipment. 2. Review, execution and compilation of qualification protocols and documents for equipment, instruments, systems, including of utilities, manufacturing process, packing equipment. 3. Preparation of yearly and add-on schedule for Periodic Performance Verification-Performance Testing (PPV-PTS). 4. Preparation of yearly and add-on schedule for Periodic Performance Verification-Support Programme Review (PPV-SPR). 5. Follow and ensure compliance of validation SOPs, policy documents and written procedures. 6. Follow and ensure the current Good Manufacturing Practices as per applicable SOPs. 7. Provide training to the personnel involved in qualification and validation activities as & when required. 8. Arrangement, Tracking, Preparation, Review & compliance for the document required for Inspection at site. 9. Co-ordination with CFT for smooth functioning of qualification activity. 10. Any other responsibility that may be assigned by HOD or reporting manager from time to time. Secondary Responsibility 11. Participation in quality improvement projects. 12. Extend need based support to DF Sites, viz. Sun Pharmaceutical Industries Limited (SPIL), India sites and Overseas DF locations. 13. Any other responsibility that may be assigned by HOD or reporting manager from time to time. Interested candidates can send resumes to akash.gogoi@sunpharma.com Job Location: Palashabri, Assam, Guwahati Contact No: 8473959757

Job Description Candidate should have sound knowledge about upstream process development (Cell culture and Fermentation). Hands on experience of shake flask studies including sample analysis and documentation. Experience in handling and operation of cell culture and microbial related experiments in bioreactor including sample analysis and documentation. Aseptic handling of seed inoculum and its maintenance Independently handle media and feed preparation for conducting studies. Should be able to trouble shoot in case of any deviation from process/parameter. Good documentation practice. Should be able to perform cell culture (IPQC) analysis. Preparation of SOP, Support for Equipment qualification, Calibration pertaining to Upstream process as per laid down procedures Ensure quality compliance in Biotechnology Upstream laboratory as per Quality standards requirements

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process Validation/Stability batches/Commercial batches. 9 Preparation and Review of Master Batch Manufacturing Records and Master Batch Packaging Record for Process Validation / Stability Batches / Commercial Batches and other relevant documents. 10 Review, execution and implementation of Batch Manufacturing Records, Process Study Protocols and Process Study Reports. 11 Management of day to day product related activities for timely execution of the assigned products through internal communications with internal departments like Purchase, Store, QA,QC,HR & Admin, Engineering, Maintenance team etc. and external communications with Tooling vendors and Equipment manufacturers. 12 Maintaining the department in accordance with the CGMP norms. 13 Responsible for initiation, assessment and closing of any deviation and change control regarding to manufacturing activity. 14 Work distribution to production officer and production operator. 15 Any work assigned by the Dept. head after proper training. 16 To raise the indent and capex as per requirement. 17 Activities other than defined in the are to be done, as per the requirement of HOD, by following HOD s instructions and guidance.

Brief team/department description: The Analytical Development department in the science organization at Azurity Pharmaceuticals is responsible for developing new analytical methods for the new dosage forms to ensure their quality. Principal Responsibilities: Responsible for the development of analytical methods for product development, primarily for sterile dosage forms and/or oral dosage forms. Responsible for the preparation of method development reports, validation protocols and reports, and test methods. Accountable for performing routine analytical testing for assigned projects, as per requirements. Responsible for executing Analytical ATR (Analytical Testing Reports), documenting results, and sharing findings with the concerned formulation development (FD) team. Accountable for the calibration of assigned equipment, qualification of working standards, and maintenance of standards per storage conditions. Responsible for conducting forced degradation studies and identifying unknown impurities. Responsible for executing experiments to address and respond to regulatory queries. Qualifications and Education Requirements 6-8 years of experience in Analytical Development of Formulation M. Pharm or MSc Chemistry By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

Preparation of Qualification documents: URS, DQ, FDS, Risk Assessment, IQ, OQ, PQ and Operation SOP of different equipment / instrument / utility. Initiation of change controls and CAPA related to Equipment / instrument / utility. Person should have hands on experience in qualification of autoclave, vial washer, depyrogenation tunnel, Filling Machine, capping machine, lyophilizer etc. Person should have exposure / understanding of qualification of packing equipment

JD Collaborate with cross-functional teams on equipment qualifications and IQS. Ensure IT compliance through validation processes. Develop computer system validation plans and protocols. QMS candidate shud b frm pharma industry gud communic skills. Cafeteria Office cab/shuttle Accessible workspace Health insurance Provident fund Annual bonus

Knowledge of equipment qualification, facility qualification, CSV, QMS Review of the Equipment Qualification Protocols and Final reports and Monitoring of the Equipment Qualification like IQ, OQ and PQ. Review of Qualification documents for IQ, OQ and PQ done by the Vendor/Third party related to Instrument integrated with equipment Experience in handling of QMS related activities: Change control, Deviation, CAPA Experience in drafting of technical reports, Quality risk assessment, water trend report, Annual equipment performance review report and perform gap assessment against regulatory guideline. Review of periodic validation like, steam sterilizer validation, Thermal mapping reports, HVAC qualification, LAFU/BSC qualification

Posted On 27th Jun, 2025 : The candidate will be responsible for handlinge-commerce inquiries, managing sales data in Excel, coordinating deliveries, and supporting invoice and order processing. Key Responsibilities: Handle incoming calls from IndiaMART and other e-commerce platforms. Maintain and update Excel sheets; proficiency in MS Office is essential. Assist in delivery tracking and coordinate with logistics partners. Coordinate invoice generation based on sales orders. Support daily operational tasks to ensure smooth order processing. Key Skills : Company Profile Business partner- to sell, install, maintain & service of entire range of Canon products viz Digital copiers, high end colour multi- function devices, A3 and A4 document scanners , print & document management solutions

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion of training. 7. Review of Master formula and technology transfer documents for API sites. 8. Master product label information update in Traces application as per the site requirement. 9. To provide training of SOPs, cGMP, or other modules as per the requirement. 10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc). 11. Scheduling and participation in self-audits (Sites and corporate functions). 12. Regulatory and customer audit support to sites. 13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs. 14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. 15. Participation in Quality related meetings. 16. Shall perform any other related work/projects assigned by CQA HOD/Section head.

Responsibilities: * Lead QMS implementation & compliance * Ensure product quality through data review & annual product quality reviews * Conduct BMRRs, batch releases & equipment qualifications Office cab/shuttle Provident fund

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.

AM QC Chemist for Agro chemical Industry In Saykha,Bharuch, Gujarat Job Title: Executive/Sr Executive Department: QC Experience Required: 5 to 10 years Industry Manufacturing Production Quality Qualification M.Sc Key Skills Agro Chemical QC Chemist Quality Control Executive QC UPLC HPLC GC Agro GMP Compliance We are looking for a skilled Am QC Chemist to join our team in the Agro Chemical Industry. The ideal candidate will have 6-12 years of experience and be based in [location to be specified]. Roles and Responsibility Conduct quality control tests on agrochemical products to ensure they meet industry standards. Develop and implement quality control procedures to minimize defects and improve product quality. Collaborate with cross-functional teams to resolve quality-related issues and enhance overall product quality. Analyze data from quality control tests to identify trends and areas for improvement. Maintain accurate records of quality control activities, including test results and corrective actions. Ensure compliance with regulatory requirements and industry standards. Job Requirements Bachelor's degree in Chemistry or related field. Proven experience in quality control within the agrochemical industry. Strong knowledge of quality control principles, practices, and regulations. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Effective communication and interpersonal skills. Familiarity with industry-specific software and technologies.

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.

Lead and execute qualification test programs. Perform and execute testing in compliance with quality assurance and safety requirements. Prepare test reports using data and results obtained during testing. Work with project managers and subsystem/component leads to develop and maintain project schedules. Lead complex technical projects, coordinating multi-functional teams to accomplish project objectives while meeting established schedule and budget requirements. Support preparation of requests for quotation (RFQs) and project change offers including scope statements, specifications, costs estimate, plans and schedules. Identify and define technical issues, risks, and challenges – direct efforts to successful resolution. Comply with industry, regulatory, or agency codes and standards pertinent to equipment qualification. Collaborate with design engineers to identify design features which require qualification. Provide technical guidance, direction, and collaborate with other personnel including partners such as outside labs, sub-contractors, suppliers, fabricators, and customers. Provides consult to establish qualification strategy for product obsolescence. Collaborate with project managers to address risks, estimate cost and schedule. Train and coach other engineers Maintain nuclear safety and a safe working environment. Develop and maintain effective business relationships with Westinghouse customers. Strongly Preferred EMC Seismic Qualifications Harsh Environment Qualification Mild Environment Qualification Strongly Preferred – Testing Knowledge Equipment, Components, and Systems used in Nuclear Power Plants Control Cards Modems to Breakers, Switches Cables Instrumentation & Control Cabinets Prior experience working in lab/testing environment (academic or industry lab) Mechanical and/or electrical problem-solving skills Strong organizational, planning skills, and attention to detail Highly motivated, self-starter Good judgment and the ability to prioritize a number of diverse tasks Orientation toward achieving Customer Success Effective communication, teaming and team building skills Strong technical writing ability Ability to multitask and work on multiple projects at a time Preferred working knowledge of IEEE and Reg Guide standards for Equipment Qualification Preferred experience in the nuclear industry, specifically in nuclear power plant safety/non-safety systems with working knowledge of 10CFR50 Appendix B, NQA-1, and 10 CFR Part 21 Familiar with the below regulations and standards : IEEE 323 IEEE 344 IEEE C37.82 IEEE C37.98 IEEE C37.81 Regulatory Guide 1.180 MIL-STD-461 IEC 61000-4 EPRI 102323 Roles and Responsibilities • 3 to 6 years of professional experience and Preferred working knowledge of IEEE and Reg Guide standards for Equipment Qualification • Preferred experience in the nuclear industry, specifically in nuclear power plant safety/non-safety systems with working • Knowledge of 10CFR50 Appendix B, NQA-1, and 10 CFR Part 21

QA Executive For Agro chemical Industry In Saykha,Bharuch, Gujarat Bharuch, Ahmedabad, Vadodara Job description 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

- 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

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process improvements to enhance CSV efficiency and effectiveness. Job Requirements Strong knowledge of CSV principles and regulations, including FDA guidelines. Excellent leadership and communication skills, with the ability to motivate and guide team members. Experience working in a fast-paced environment with multiple priorities and deadlines. Strong analytical and problem-solving skills, with attention to detail and the ability to identify risks. Ability to work collaboratively with cross-functional teams, including sales, marketing, and engineering. Strong understanding of quality management systems and ISO standards. Location- Bengaluru,Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli, Jammu, Lakshadweep, Nagar,New Delhi,Puducherry,Sikkim

Hiring for a manufacturing MNC company located in Gujarat. Position: Automation Software Engineer Required Experience: 5+ years Travel: 20% Employment: Permanent Key Responsibilities/Duties: Your duties will include, but not be limited to - reviewing and establishing the project scope and deliverables, design and write PLC, HMI and SCADA control system software, produce required documentation (e.g. functional design specifications, software specifications, manuals), documented software testing, carry out testing and acceptance with customer, provide support for the on-site commissioning and qualification of the equipment, commissioning of systems, train customer maintenance and operator staff, implement changes on site to electrical panels when required. Qualifications & Experience: The successful candidates will have a proven background in control systems-related software design for process/equipment control in the Life Sciences industry or a similar process control industry. Experience in the following areas are considered essential Siemens TIA PLC programming using LAD/STL, Allen Bradley Control Logix PLCs, Siemens TIA HMI configuration, control system testing and fault finding, VBA, MS Windows 10/11. A good working knowledge of standard software products is assumed i.e. Microsoft Office. Experience with or knowledge of the following areas would be considered an advantage - Siemens Step 7 PLC Programming using LAD/STL, Siemens WinCC Flexible HMI configuration, iFIX SCADA, VB, MS SQL, electrical hardware design, commissioning and qualification activities and some understanding of Life Science industry regulatory requirements i.e. GAMP, FDA. Ideally the applicant should possess the following: Relevant Higher Qualifications in Electrical / Electronic / Process Design / Automation / Software Five plus years of relevant software design experience Highly motivated, with excellent communication and organization skills. Creative approach to problem solving, and work well under pressure Experience of commissioning and fault finding on industrial equipment Experience of Automation project delivery across the entire project lifecycle Interested candidates share resume on zalak.rohit@cielhr.com

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

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