235 Sop Preparation Jobs - Page 5

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

1. Overseeing ISO 17025 Compliance: Quality Manager ensures that all processes, procedures, and documentation within the laboratory meet the requirements of the standard. They establish and maintain a quality management system to ensure compliance. 2. Developing and Implementing Quality Policies: They create and implement quality policies and procedures to improve laboratory processes. This comprises developing of standardized operating procedures, work instructions, and quality manuals. 3. Training and Development: The Quality Manager provides training to laboratory personnel on quality systems, ISO 17025 requirements, and good laboratory practices. They also ensure that all employees are aware of their responsibilities and understand the importance of quality compliance. 4. Internal Audits and Corrective Actions: Conducting regular internal audits to assess the effectiveness of the quality management system is another crucial responsibility. The Quality Manager identifies non-conformities and implements corrective actions to address them. 5. External Audits and Accreditation: Coordinating external audits by accreditation bodies is essential for maintaining ISO 17025 accreditation. The Quality Manager ensures that the laboratory is adequately prepared for these audits and assists in addressing any findings or recommendations. 6. Continuous Improvement: The Quality Manager leads continuous improvement initiatives, promoting a culture of quality within the laboratory. They analyze data, identify trends, and implement appropriate corrective and preventive actions to enhance quality performance. 7. Strong Knowledge of ISO 17025: Thorough understanding of ISO 17025 requirements and experience in implementing and maintaining the standard within a laboratory setting. 8. Quality Management Experience: Previous experience in quality management, preferably in a testing or calibration laboratory, with a focus on compliance, audits, and process improvement. 9. Excellent Communication Skills: Effective communication is crucial to interact with laboratory personnel, accreditation bodies, and other stakeholders. The Quality Manager should have strong verbal and written communication skills. 10. Attention to detail: The ability to pay meticulous attention to detail is essential to ensure compliance with ISO 17025 requirements and to identify areas for improvement. 11. Analytical and Problem-Solving Skills: The Quality Manager should be skilled in data analysis, root cause analysis, Risk analysis and implementing effective corrective and preventive actions. Educational qualification & experience: M.SC. in Science or Graduate in Engineering with 8-10 years experience in NABL accredited Testing Laboratory.

JD SAP PI/POCollaborates with cross functional IT business analyst team to review the integration requirements and recommend best integration solutionsDesign, build, support interfaces; develop and maintain data mappings, JAVA mappings, XSLT mappings, EDI and XML communications, PI Proxies, interface definitions, and XSDsDevelop and maintain Integration Repository (Interface Objects, Mapping objects and Adapter objects), Integration Directory (Communication channels, Sender and Receiver agreements, Receiver and Interface determination) and Integration Engine (Central Monitoring)Develop interfaces using adapters available in PI: File, FTP, SFTP, HTTP/HTTPs, PROXY, JDBC, SOAP, SQL, ALE and IDOCSet up error handling for interfaces and participate in monitoring with various components in Runtime Workbench like Message Monitoring, Component Monitoring, End to End monitoring and Performance AnalysisWrite technical documents to support the functional specifications and other efforts Support, monitor, and troubleshoot production systems; optimize performance and resolve production problems Shift Timings:ILS TZ (3:30pm 12:30am IST) Work Location:WFH during Pandemic period and later to work from TechM location (Hyderabad is preferable but Blore is also ok)No Subcons are allowed Position open for Full Time Employees of TechM only

Carry out manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control production parameters to meet quality and output targets. Ensure timely completion of batches to meet production schedules. Ensure adherence to current Good Manufacturing Practices (cGMP) and company policies. Report and document any deviations, incidents, or abnormalities during production. Operate, clean, and maintain manufacturing equipment (e.g., granulators, blenders, tablet compression machines, filling machines). Perform line clearance, changeovers, and cleaning as per SOPs. Maintain accurate and timely records of all production activities. Fill out logbooks, checklists, and BMRs/BPRs (Batch Production Records) as per regulatory standards. Coordinate with QA, QC, maintenance, and warehouse departments to ensure smooth workflow. Support validation activities, including equipment qualification and process validation.

Direct contact for major FTL clients Drive account growth through cross-sell/up-sell strategies Analyze account KPIs: OTIF, damage rate, transit delays Prepare & present performance reports & MIS Manage onboarding of new clients SOPs pricing planning Required Candidate profile 10yrs of exp in Road Freight/FTL operations In-depth knowledge of the Indian FTL market, contracts & fleet planning Strong client engagement, negotiation Proficient in MS Excel, PowerPoint, CRM tools

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.

Dear Candidate, We are conducting walk-in drive on 27th June (Friday) for the positions in our Quality Assurance department. Job Description : Position Name: Fresher/Executive Experience - 0 -5 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Walk-in Date: 27th June 2025 (Friday) Time: 09:00 AM to 12.00 PM Chemveda is hiring for Quality Assurance Executive Position Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications and review of Analytical LNBs. 6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products. 7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects. 8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet. 9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections. 10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO). a. Circulation of Non-compliances b. Circulation of Non-Compliance reports to CMO 11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs. 12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation. 13. Review of weekly and monthly reports and collecting data. 14. Monitoring of QMS activities as per ISO & Client requirements. 15. Document issuance, retrieval and archival, document control. 16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures. 17. Preparation quality system procedures and quality manual. 18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle. Interested candidates can attend walk-in drive or share their profiles to saivardhan.kothuri@chemvedals.com

We are seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines. Key Responsibilities: Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control. Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution. Review and approve Master Production Records, Batch Production Records, and Validation Protocols across departments. Coordinate process, cleaning, and analytical method validations as per the Validation Master Plan. Prepare, review, and manage regulatory documentation including DMFs/ASMFs in CTD format (Modules 1, 2, 3). Liaise with regulatory authorities and customers for audit readiness, document submissions, and compliance queries. Oversee training programs for plant personnel and ensure continuous adherence to GMP standards. Conduct Product Quality Reviews and implement risk management tools like FMEA, HACCP, and HAZOP where applicable. General Requirements: Thorough understanding of global regulatory guidelines (ICH, WHO, USFDA, etc.). Strong analytical, documentation, and decision-making skills. Proficient in regulatory submissions and quality review documentation. Familiarity with stability studies and establishing expiry/retest periods. Hands-on experience with validation protocols and equipment calibration systems. Ability to lead cross-functional teams and ensure site-wide compliance. Excellent verbal and written communication skills. Willingness to take ownership and drive continuous improvement initiatives.

Role & responsibilities To maintain the QA documents in compliance state and ensure they are all time ready for internal and external audits. Preparation and review of SOPs. To act as training coordinator and oversee implementation & compliance of training matrix. To maintain the vendor approval document. Daily issuance and retrieval of records of other departments. To maintain records of change control, deviations, CAPA, incidents logs, OOS, OOT. To prepare and maintain calibration and validation schedules of equipments as per VMP. Upkeep and follow-up for new product licenses. To prepare APR, trends. Prepare and review of BMR and analytical reports. Upkeep of retain samples and controls samples and their records. To maintain GMP in the plant and identify problem areas and report to Head-Quality. Line clearance in dispensing and production area. To perform in-process sampling, testing and document the observations. To handle IPQA activity in warehouse and production area.

Supervise and coordinate QA lab personnel and activities related to sampling, testing, and reporting of raw materials, in-process samples, and finished products. Ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory guidelines (e.g., FDA, ISO, ICH, etc.). Review and approve analytical test results, COAs (Certificates of Analysis), and related documentation. Manage calibration, maintenance, and validation of laboratory instruments (e.g., HPLC, GC, UV-Vis, FTIR). Investigate out-of-specification (OOS), out-of-trend (OOT), and non-conformances; participate in root cause analysis and CAPA implementation. Ensure timely completion of stability studies and trending of data.

Knowledge of Method Validation & verification as per Pharmacopiea requirement. To perform Method Validation & verification of Chromatographic GC / HPLC methods. Preparation of specification in DMS & SAP system. SOP preparation related to AMD work. Required Candidate profile Candidate Must be MSc Regular. AMD protocols & report preparation, non-chromatographic methods. Maintain require stds & Impurities stock, list etc. Operation of instruments like HPLC,GC,UV,IR etc.

Hiring HR & People managment role to handle end-to-end HR tasks—recruitment, onboarding, employee engagement, admin & compliance. Need 5–10 yrs HR experience needed, with ability to build systems from scratch. Startup/tech experience preferred,

Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed. 6.0 To Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. 7.0 Knowledge on computerized system inventory and GxP risk classification/ Impact Assessment. 8.0 Review and preparation of URS, FS, IQ, and OQ documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems. 9.0 Knowledge on Audit trail review. 10.0 Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements. Preferred candidate profile

Role & responsibilities Job Responsibilities/Descriptions 1.0 Knowledge on Guidelines (ISPE, PDA, ICH) regulation (FDA & EMA). 2.0 Participate in Equipment, Area, Utilities and Facility qualifications. 3.0 Preparation and Review of URS, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Commissioning Studies, and SOPs related to Equipment/systems. 4.0 To monitor the Performance Qualification of various equipment and systems at site. 5.0 Review of Performance Verification protocols and reports. 6.0 To be part of process validations studies like Washing Validations, Mixing Validations, CIP and SIP validations, Filling Validations, Capping Validations, Autoclave, DHS Validations and providing support for preparation and review of summary report. 7.0 Review and verification of Calibration, Preventive Maintenance and Annual Maintenance records of equipments related to GMP Area. 8.0 Handling of Qualification related change controls, Deviation and CAPA initiation and closure. 9.0 Handling and knowledge on breakdowns, Notifications, and clearance request. 10.0 Basic knowledge on 21 CFT part 11 requirements. 11.0 Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. Identify and mitigate risks related to computerized systems at the site level. 12.0 Preparation and review of the SOPs related Qualification, validation (Including CSV) and review of Engineering SOP. 13.0 To ensure the Audit trails and data integrity compliance for GxP computerized systems. 14.0 Reviewing and approving (or rejecting) validation or qualification protocols and or reports. 15.0 Providing Quality oversight on engineering activities. Knowledge on Preventive maintenance and Calibration. Preferred candidate profile

Key Responsibilities: Production Planning: Develop and implement production schedules to meet customer demands and optimize resource utilization. Quality Assurance: Monitor product quality and implement quality control processes to ensure adherence to specifications and standards. Team Leadership: Supervise and motivate production teams, providing guidance, training, and performance feedback. Process Improvement: Identify opportunities for process enhancement and implement strategies to improve efficiency and reduce costs. Inventory Management: Oversee inventory levels and ensure availability of materials and components needed for production. Safety and Compliance: Ensure compliance with health and safety regulations and company policies to maintain a safe working environment. Qualifications and Skills: Proven experience as a Production Manager or in a similar role within the electronics industry. Strong knowledge of manufacturing processes and quality standards. Excellent leadership and communication skills. Problem-solving and decision-making abilities. Bachelors degree in Engineering, Manufacturing, or a related field (Electronics industry). Excellent command on mail writing and report. Maintain good relationships with customers and other stake holders, responsive to internal and external team. Manpower planning & allocation of people on the manufacturing lines during the shifts. Maintaining optimum stock of critical tools and spares to achieve production target. Good knowledge of PCB and Electronics Components and able to troubleshoot PCB. Strong knowledge of Inventory management tools like ERP, IMS, SAP etc.

2-7 years of overall experience in Tax Basic knowledge of tools and systems ( JDE MS Office) Basic understanding of US Tax regulations Conversant of various online tools and systems Monthly income tax accrual procedures Preparation of Tax Account Roll forward with cash tax payment support Assist in month close tax related activities Completion of tax reporting process Assist in the monitoring of the tax reporting process Contact Person: Subhikshaa Contact Number : 9840114687 Email : Subhikshaa@gojobs.biz

We are seeking a skilled and proactive Production Engineer to join our team in Pune. The ideal candidate will have a strong background in plastic injection molding and hands-on experience in managing production processes, optimizing efficiency, and ensuring quality standards. This is a key role within the Production Engineering department focused on driving continuous improvement and supporting manufacturing operations. Key Responsibilities: Plan, manage, and monitor daily production activities to ensure smooth operations and on-time delivery. Optimize machine utilization and manpower allocation to maximize output and efficiency. Troubleshoot process and equipment issues in injection molding operations. Coordinate with design, maintenance, and quality departments to resolve production challenges. Develop and implement standard operating procedures (SOPs) and ensure adherence on the shop floor. Support the introduction of new molds, machines, or products in coordination with relevant departments. Ensure compliance with safety and quality standards throughout the production process. Maintain accurate production records and generate reports for performance analysis. Drive continuous improvement initiatives such as lean manufacturing and 5S. Candidate Profile: Minimum 4 years of relevant experience in a production engineering role within the plastic injection molding industry. In-depth knowledge of injection molding processes, machines, and tooling. Strong problem-solving and decision-making skills. Good understanding of production planning, quality control, and process optimization. Ability to work independently and as part of a cross-functional team. Proficient in MS Office; familiarity with ERP systems is a plus.

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance of Akta systems, Tangential flow filtration, centrifugation etc. To involve in daily lab activities for process development and assist fellow researchers. LOCATION : Hyderabad. CTC : 4.5 LPA IMMEDIATE JOINERS ARE PREFERABLE" Interested candidates please attach your CV here. NOTE : Interviews will be face to face only ,no virtual interviews. For more details, please reach out Venkat - 9381915043

Role & responsibilities Job Responsibilities/Descriptions Primary Responsibilities: 1. To ensure shop floor compliance of Visual Inspection, Packaging, warehouse and Dispatch operations as per cGMP and cGWP requirements (IPQA activities). To prepare and review SOPs, study protocols, SPRs, TPRs pertaining to Fill finish, warehouse and quality assurance as required. 3. To Support in visual inspection qualification kits and visual inspection operator qualifications. 4. To review the trends of visual inspection results. 5. To support the Validation Team during the qualification activities at the area. 6. To provide Line Clearance for Visual Inspection, Packaging, Dispensing and Dispatch operations, verification of In-Process checks as defined in the batch records / SOPs. 7. To perform AQL Visual Inspection of filled units as per SOP / instructions. 8. To perform Pre-Dispatch Inspection (PDI checks). 9. To verify and ensure routine compliance of Visual Inspection and Packaging activities as per the batch records/SOPs and verification of the online documentation against each process stage, including logbooks 10. To Suppott Artwork development and management. 11. To Support in Transport Validation of Finished Products. 12. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to Visual Inspection and Packaging areas, support investigations. 13. To co-ordinate with all cross functional departments for operations related to Quality Assurance. 14. To ensure the readiness of shop floor for audits by Regulatory Authorities / customers. 15. To support market compliant investigations. 16. Ensure to perform daily random checks on material reconciliation at warehouse and report the discrepancy. 17. Ensure the warehouse documents verification and its compliance. 18. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to warehouse and Dispatch areas; support investigations. Secondary Responsibilities: 19. Follow the safety precautions at packing and warehouse areas. 20. Support the internal audits. 21. Any other responsibilities assigned by supervisor / head of the department.

Role & responsibilities 1) SOP Preparation 2) Daily/ Weekly/ Monthly/ Yearly Audit preparation 3) Internal Audit 4) ISO Audit Preparation 5) Daily MIS preparation 6) Monthly PPT submission and collection from department 7) All department documentation checking Preferred candidate profile

Senior Project Owner (SPO) Utility/Energy Division Job Title: Senior Project Owner (SPO) - Utility & Energy Division Company: ARDEM Data Services Location: Remote Shift: 6:00 PM to 3:00 AM About Us: ARDEM Data Services is part of a US-based global professional services company providing Business Process Automation and Business Process Outsourcing Services. We are seeking experienced Senior Project Owners (SPOs) specializing in Utility & Energy Sector projects. This role requires expertise in utility bill processing, energy data analysis, and workflow development to optimize operational efficiency. Responsibilities and Duties: Project Management: • Manage and oversee multiple utility and energy sector projects concurrently, ensuring timely and budget-friendly execution. • Serve as the main client liaison, ensuring clear communication and alignment on project expectations. • Develop project plans, milestones, and performance metrics to track progress effectively. Team Leadership: • Lead and manage a team of process analysts handling utility data processing. • Assign responsibilities based on expertise, ensuring efficient resource utilization. • Conduct team huddles and performance reviews, providing feedback for improvement. Quality Assurance: • Act as a quality checker, ensuring utility bill data processing meets high accuracy standards. • Implement quality control measures, including Root Cause Analysis (RCA) and Corrective Actions. • Maintain HQC, DQC, and FQC checklists for project tracking and final quality control. Process Improvement: • Analyze utility data processing workflows and recommend efficiency improvements. • Implement automation and best practices for utility billing and energy consumption data. • Keep processing logs, work instructions, and process maps up to date. Workflow Development: • Design and develop workflow processes for utility bill audits and energy data reconciliation. • Create training plans and ensure all team members are proficient in handling utility sector projects. Client Communication: • Communicate effectively in English with utility and energy clients to clarify project requirements. • Provide regular updates on progress, challenges, and resolution strategies. Required Experience, Skills, and Qualifications: • Bachelor's degree (Preferred: BTech- Engineering background only)) • 12 years of utility project management experience, with at least 7+ years in a leadershiprole • Experience handling utility bill processing, energy data analysis, or sustainability reporting • Ability to manage 15-20 projects with teams of 1-5 analysts or a single large project with30-50 analysts • Expertise in utility bill formats, energy consumption analysis, and ESGreporting • Strong understanding of data processing workflows, automation, and regulatory compliance • Proficiency in developing Training Plans, Quality Plans, and Standard Operating Procedures (SOPs) • Experience with Root Cause Analysis (RCA) and Corrective Action Plans (CAPs) • Strong English communication skills, with the ability to present confidently in video calls and client meetings Technical Requirements: • Laptop or Desktop: Windows (i3/i5 or higher, 8GB RAM minimum) • Screen: 14 inches, Full HD (19201080) • Internet Speed: 100 Mbps or higher

Role & responsibilities : Responsible for following activities: Handling of Change controls, Deviations, Market complaints, CAPA and other QMS Documents. Participate in investigation of Nonconformities. Participate in quality risk management and maintain its record. Preparation and review of Product Quality Review Report (APQR). To execute product recall and mock recall activities. To coordinate for management quality review meeting. Handling of internal audit activities and compliance with CAPA. Preparation and review of SOPs, SMF, Quality Manual Preferred candidate profile ERP/ QMS software system handling experience

PVSyst and Advanced Excel for solar plant performance analysis, including monthly simulations and energy modeling. Skilled in stakeholder communication, SOP preparation, record-keeping, and contractual deliverable monitoring operational efficiency. Role: Other Industry Type: Power (Solar) Department: Other Employment Type: Full Time, Permanent Role Category: Other Education UG: B.Tech/B.E. in Electronics/Telecommunication, Electrical