433 Capa Jobs - Page 15

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. About The Role : The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Good knowledge about sampling plan and IQC control plan,Should know the Incoming quality control lab process in any EMS industry,Should know prepare the SOP & SIP and LRR,Daily basic process schedule & Tracking.Skill in yield and production process in EMS. Incomming Quality Control, Supplier Quality Engineering,,Online Relaiability Test,Process Quality Control, 1. Responsible for Leading the Quality function and day to day In-process Quality verification with consistent result both in terms of Quality and Quantity to meet daily plant output/customer requirements. 2. Performing in-process quality inspection for accuracy, specification parameters and workmanship. Develop and implement best quality processes in production 3. Tabulate and document data relating to products, processes, materials, its qualities, and reliabilities 4. Train staff, technicians, and professionals on the aspects of quality control activities. 5. Troubleshoot and resolve problems relating to quality using quality tools (DMAIC, 8D, 4Q, PDCA etc.) Capture and analysis of COPQ in order to achieve savings. 6. Conducting regular Inspections and Audits to assess product quality and compliance with established standards 7. Collaborating with production teams to Identify areas for improvement and develop solutions to address quality Issues.

Ensure compliance with quality standards throughout the production process. Manage & maintain customer documentation, including PPAP (Production Part Approval Proces Must have complete knowledge and expertise with regards to -IATF ,MSA,SPC ,PPAP,APQP Required Candidate profile Liaise with the production and engineering teams to implement quality improvements. Support training and continuous development of team members related to quality standards.

Key Responsibilities Be a part of sustaining project team and work in the design quality engineering across the entire product cycle. Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable) Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products. Manage electronic document control and version control on all project related documents. Ensure adherence to the quality systems and design assurance SOPs and customer’s PLCP. Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution. Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Acts as an effective communicator or team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. For those individuals that supervise others, the following statements are applicable: Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Customer’s Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System. Job Scope and Leveling Guidelines Functional Knowledge Requires expanded conceptual and technical and/or functional knowledge in Medical Device Design Quality domain. Broadens capabilities in applying concepts in job function. Business Expertise Demonstrates working knowledge of business and industry practices and company processes to accomplish own work. Leadership No supervisory responsibility; accountable for own contributions and meeting objectives. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules. Problem Solving Uses and exercises judgment to solve problems in straightforward situations and determine appropriate action/solutions. Works under general direction from more senior level roles/manager Candidate should have 5+ years of experience

Key Resp Collaboration: Work closely with procurement, engineering, and production teams to ensure supplier quality aligns with company requirements. Knowledge on APQP, PPAP, MSA, SPC, FMEA, CONTROL PLAN, PFD till latest edition as per IATF Health insurance Travel allowance Mobile bill reimbursements Career break/sabbatical Performance bonus

1.Responsible for batch record issuance. 2 Responsible for issuance of change control 3.Resposible for implementation of ISO & Quality Management System 4. Responsible for calibration & validation of Equipements & Instruments 5. Responsible for inprocess Quality Checks 6.Resposible to implement CGMP 7. Responsible to monitor product activity 8. Responsible for issuance & retrival of control document 9. Resposible for dispatch verification 10. resposible to prepare process validation proyocal & record

Inspect raw materials and finished products for quality Ensure consistent quality throughout the production process Perform quality & assist in equipment calibration Maintain inspection records & assist with quality reports Required Candidate profile Education:- Diploma or Bachelor’s in Printing Technology, Packaging, or related fields. Experience:- 0-2 years in Printing and Packaging Industry

JD- • Ensuring quality and regulatory compliance as per ISO 9001:2015 standards •Coordination with design, manufacturing and other functions to reduce defects in the systems •Identification of new vendors and evaluate their technical, commercial .

SOP | Kaizen | Quality Management | Continuous Improvement | Control Plan | Fmea | QMS | Quality Audit | RCA | QA | 8D Problem Solving | Capa | MSA Study | Problem Solving Tools | Why-why Analysis | Kaizen Implementation | 7Qc | 5S System |

Role & responsibilities Managing the Quality and Information Security Management System and ensuring GMP compliance is incorporated. Agreeing standards and establishing clearly defined quality methods for staff to apply. Liaising with clients auditors and ensuring the execution of corrective action and compliance with clients specifications. Identifying relevant quality and GMP related training needs and delivering training. Guiding the relevant stakeholders on quality and regulatory requirements on innovation projects. Function as an internal auditor for QMS, ISMS, and BCP as required. Managing and developing the Document management system. Ensuring the CAPA system is managed with the objective of continuous improvement. Ensuring compliance with appropriate standards and regulation. Ensuring external audits for critical suppliers are attended to or led by a member of the quality department. Drive on-time closure of all observations, opportunities for improvement and NC’s (if any). Complying with SOPs (Standard Operating Procedures) and Work Instructions as detailed on Training Records and Training Matrixes. Effectively interact with the company departments to ensure the delivery of the product to specification and promote the improvement of the QMS. Updating of Quality Records, as detailed in the appropriate SOPs. Comply with Perigord centralised Global Quality and Information Security Management System. Provide daily / weekly update over email and review calls to the Quality Manager and Global Head of Quality Preferred candidate profile Bachelor’s degree qualification in a life science, technical or engineering discipline. 4+ years of relevant Quality Assurance or relevant experience in Life science and or Software services company Demonstrate excellent communication skills (oral as well as written) Ability to work with minimum supervision. Ability to work within a challenging environment with tight delivery timelines. Additional Desired Preferences: Knowledge of Computer System Development Life Cycle Good technical understanding of IT infrastructure Experience dealing with regulatory agencies and global audit teams.

Testing methods - Mechanical, Physical & Electrical is essential Handling Various measuring Instruments. Customer Complaints- Investigation and analysis, reduction Documentation ofISO, IATF 16949,and otherQMS,5S,Kaizen. Audits

Set up approval & In process inspection as per control plan. KPI target.Layout inspection of Casting as per developement planTPM', "5S" or "SAFETY WEEK" etc.Kaizens Closure -non conforming occurs,CAPA, Process Audit, Product Audit, CFT NPD,QSR Required Candidate profile Give NC,Instrument,gauges handling.skills of subordinate,prepare training need,CFT for new product development.ensure availibility of required drawing/gauge/instrument/customer standard/SOP,SPC/MSAQSR

inward inspection as per quality plan,Product audits,CAPA,DOCK audit, CFT-NPD.drawing/gauges/instruments/customer standard/SOP,SPC,MSA Inprocess at supplier end,supplier Audit, KPI,5s,TPM,Kaizen,Raise 8D/ MOM for supplier if NC,new supplier selection Required Candidate profile Shd be responsible to answer the Customer Complaints.Quality Documentation Knowledge,Face the Audits like ISO, EHS, IITF etc.Inhouse Rejection Analysis.calibration of gauges/instrument at supplier end

1. To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material. 2. Assistance in preparation of SOP of various departments/ preparation of draft SOPs. Required Candidate profile To review manufacturing, store, QC activity. To prepare approved vendor list and maintain vendor qualification. To Attend QR meeting as per schedule Call/ Whatsapp : 91-9327657730 / 9724346949

collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications. Ensure that all necessary documentation is completed accurately Call: 91-9327657730 / 9724346949 Required Candidate profile Nitrosamine Impurity, Elemental impurity, Genotoxic Impurity & their role related DMF Filing. Preparation & review (MOA), standard testing procedure (STP) and other documents related to QC.

Role & responsibilities Physical checking of RM/PM Material with verification documents & labelling. To check the material is Received from Approved Vendors. Arrangement of Materials at proper designated areas. To Prepare GRN in SAP for Received of incoming material. To intimate Q.C. Department for Material sampling and after that the materials to be shifted on approved or rejected area. Material requirement Received from Production Department & Issue as per that, also issued material weight verify as per issued requirement. To maintain Physical Stock of RM/PM. To maintain all log books. To maintain Cleaning Record & supervision of all dispensing location with logbooks To prepare stock valuation every month. Corresponding with Head office. Maintain narcotics, MA-I, RS-II stock & record. GRN for Received of RM/PM in SAP Co-ordinate with Production, Purchase, QA-QC and Other Department. To Raise Purchase Requisition as per Production planning and to ensure availability of material on time. Co-ordinate with cross functional teams & purchase as well with management for smooth operations Material receiving, warehousing, distribution and maintenance operations. Ensure that the store is kept clean and organized To maintain of SOP trainings, CAPA, Deviation and Change Control. To maintain standards of health, hygiene, safety and security. To maintain stock control and reconcile with SAP.

* Quality Strategy and Leadership * Regulatory Compliance * Quality Management Systems (QMS) * Product Quality Oversight, Risk Management * Compliance and Documentation * Internal and External Communication Required Candidate profile * Supplier and Vendor Quality Management * Cross-Functional Collaboration * Candidate should have experience in Pharma / API manufacturing Company.

CANDIDATES HAVING EXPERIENCE IN EXTERNAL / TOPICAL PREPRATIONS (Ointment, Creams, Gels) WILL BE GIVEN PREFERENCE. Key Responsibilities: Review and verify quality-related documents and procedures. Handle change control, deviations, and impact assessments. Manage incidents, investigations, and CAPA implementation. Oversee market complaints, product recalls, and mock recalls. Prepare and review SOPs, validation protocols, and reports. Ensure compliance with batch manufacturing and packing records. Monitor shop floor activities for quality assurance. Implement and manage quality control processes. Perform other tasks as assigned by management. Preferred candidate profile Required Qualification: - B.Pharma/M.Pharma Industry : Pharmaceutical Formulation/API Experience: 06 - 11 Years Role: Sr.Officer/Executive Department: Quality Assurance Employment Type: Full Time, Permanent CTC: Will depend on Current CTC & Interview Performance.

CANDIDATES HAVING EXPERIENCE IN EXTERNAL / TOPICAL PREPRATIONS (Ointment, Creams, Gels) WILL BE GIVEN PREFERENCE. Position Overview: As an Assistant Manager in the Quality Assurance department at Universal Twin Lab in Silvassa, you will play a pivotal role in ensuring compliance, quality, and operational excellence within the pharmaceutical manufacturing environment. Reporting directly to the Quality Assurance Manager, you will assist in leading a team responsible for validation, qualification, quality management systems (QMS), documentation, and overall compliance. Role & responsibilities Lead QA team in ensuring compliance and quality standards. Oversee QMS activities including change control, deviations, complaints, recalls, and CAPA. Assist in process validation for oral solid dosage forms. Coordinate equipment and utility qualification activities. Review and approve master documents and reports. Participate in audits and inspections. Monitor daily QA activities and prepare regular reports. Preferred candidate profile Required Qualification: - B.Pharma/M.Pharma (MALE Only) Industry : Pharmaceutical Formulation/API Experience: 10 - 15 Years Role: Assistant Manager QA Department: Quality Assurance Employment Type: Full Time, Permanent CTC: Will depend on Current CTC & Interview Performance.

Role & responsibilities : Candidiate should have the experience of gear manufacturing maintenance. Responsible for shift B/Ds P , PM & other planned activities , planning and undertaking scheduled maintenance, responding to breakdowns, diagnosing faults, repairing equipment, supervising fitters and Electricians. Minimize machine breakdown hours to meet set objectives. Control and monitor Mean Time Between Failures (MTBF). Track and reduce Mean Time to Repair (MTTR). Implement energy-saving and conservation measures. Drive cost-saving projects with a focus on continuous improvement. Focus on in-house repair activities. Manage and monitor required spare parts effectively. Perform root cause analysis and implement corrective/preventive actions. Promote continuous improvement initiatives. Supervise maintenance activities to minimize production disruptions and ensure compliance with industry regulations. Manage breakdown maintenance, troubleshoot issues, and execute repair and installation activities per plan. Lead shift operations independently, track breakdowns, and prepare daily/weekly/monthly MIS reports. Drive continuous improvement in autonomous maintenance with the production department. Ensure EHSMS and QMS documentation and audits are completed effectively. Other Responsibilities : Identify critical machine and TPM implementation. Provide technical support of the Kaizens and Poka Yoke proposed and initiated. Implement Energy monitoring projects. Take appropriate actions to minimize part rejections due to machine breakdowns. Accountabilities: Increased machine breakdowns Unsafe machine conditions Non-adherence to safety guidelines Energy Wastage.

Job Description Job Title: GCP Lead Employment Type: Full time Location: Bengaluru/India Experience: 5-8 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Canada, the United Kingdom, Italy, Poland, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities ¢ Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement.. Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable. Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals. Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance. Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans. Facilitating regular CAPA status and metric reports to ensure senior management awareness. Participating in governance/oversight activities including trend assessment or other quality review. Knowledge in the area of Clinical Operations is preferred. Required Skills and competencies: Quality Assurance Nonconformance management (CAPA, Deviations, Issues) GCP Stakeholder management Conflict Resolution Problem Solving

Work Location: Naidupet (Near TIrupati) Role & responsibilities 1. Handling of market complaints. 2. To acknowledge the complaints to the reporter 3. conducting complaint Investigations 4. Co-ordinate with functional investigators (Cross Functional Team/Subject Matter Experts) for timely completion of complaint investigations. 5. Follow up for complaints closure letter from the Reporter and close the complaint in complaints closure form. 6. Involve in root cause analysis, Failure Investigations and Risk assessment activities. 7. Initiate, review of Corrective action & preventive action and To prepare trend of complaints. To Maintain all the Quality management system documentations. Preferred candidate profile B. Pharma/Msc Educational qualification with 03 to 08 years experiance Perks and benefits Best In industry

Role & responsibilities Cross functional and within department co-ordination to ensure all the Change controls, Exceptions, Process non-conformance and Material non-conformance for the closure within due date. Responsible for all the change control coordination activities, Coordination with customers for approval of change controls in Quality management system module Monitor and to trace the Change controls, Exceptions, Process non-conformance and Material non-conformance in Quality management system Initiate, review the Corrective action & preventive action and to coordinate with other departments for its closure within due date. Prepare and review the trends for Change controls, Process non-conformance and Material non-conformance, Exceptions and Corrective action & preventive actions Preferred candidate profile 02 to 07 years pharma formulations experience preferrable. Perks and benefits As per Industrial standards

Qualification: Regular M.Sc. (1st class is mandatory) - 60% Throughout in All Streams Work Experience: 6– 12 Years (In the field of QA in Pharma/Chemicals/Agrochemicals)

Role & responsibilities Develop and implement quality control procedures and guidelines. Monitor production processes to ensure compliance with quality standards. Conduct regular inspections and tests of raw materials, in-process components, and finished products. Identify and address any quality issues, deviations, or non-conformities. Document and maintain accurate records of quality inspection results and corrective actions taken. Collaborate with production teams to develop and improve quality control processes. Analyze quality data and generate reports to track trends and identify areas for improvement. Train and educate employees on quality control procedures and standards. Work closely with suppliers and vendors to address quality-related concerns. Stay updated on industry regulations and best practices in quality control. 8D model, exposure of Audits (Internal, External, Process), RCA, CAPA, 6S. Inspections. Understanding of UTM machine. . Preferred candidate profile Bachelor's degree in a relevant field, such as Quality Management or Textile Engineering. Proven experience in a quality assurance or quality control role. Strong knowledge of quality control principles and practices. Attention to detail and ability to work with precision. Proficiency in using quality control tools and software. Knowledge of relevant quality management systems and standards. Ability to collaborate effectively with cross-functional teams. Certifications in quality management (e.g., Six Sigma, ISO) are a plus. Good in excel and powerpoint.