433 Capa Jobs - Page 17

Role & responsibilities Job responsibilities comprise carrying out of Quality Assurance functions in day-to-day activities. JOB RESPONSIBILTY 1. Responsible for review, approvals and close outs of change controls, deviations, CAPA, incident reports and any other quality system documents 2. Develop, manage and improve Quality Systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities 3. Review and approvals of analytical and formulation development Master documents. 4. Review and approval of analytical activities protocols and reports 5. Submitting whole set of documents required for regulatory submissions for new products 6. Supporting for any regulatory queries from QA perspective 7. Review and approval of validation, qualifications protocols and reports, 8. Monitoring day to day activities in Analytical development and Formulation development in compliance to the GMP 9. Preparation, review and approval of SOPs 10. Conducting training on SOPs, quality management systems and GMP in all aspects including procedural updates 11. Control of documents includes documents storage, issuance, distribution, retrieval and destruction 12. Performing vendor audits of API and Excipients (where necessary) and handling of all activities related to vendor audits 13. Conduct periodic audits of CMOs and Althera affiliate facilities. Participate in the vendor Qualification programme as and when needed. 14. Review and approve change control initiated at CMOs and co-ordination with European QA, RA aid customers and keep track till all the relevant activities are completed 15. Planning and conducting of self-inspection, preparing and sending self-inspection reports to concerned departments. Verifying the self-inspection compliance report for correctness and completion 16. Oversight and coordination with the Contract Manufacturing Organization (CMOs) on batches manufacturing activities as well Quality Management functions for Althera products 17. Coordination with the European QA team on supplying necessary QMS documents as required 18. Responsible for review, approvals and close outs of deviations, CAPA, OOS, OOT and incident reports raised by the CMOs. Timely review of effectiveness of CAP As. 19. Participate in investigations at the CMOs where necessary, review and ensure the investigations are conducted in line with the current regulatory expectations. 20. Applying risk management tools wherever applicable in accordance with current regulatory requirements 21. Handling of Market complaints and to co-ordinate with respective CMOs to get the investigation done on timely manner with appropriate root causes and CAPAs identified. 22. Track all the QMS status of Althera products at CMOs are timely concluded, and reports are shared 23. Coordinate with CMOs in any Regulatory and customer audits at their site, track all the observations and the CAPAs are completed timely as per the commitment. 24. Review and approve of CMOs validation and master documents (BMRs, BPRs, MFR, PVPs, PVRs etc) and Protocols (Validation, Qualification, cleaning, stability etc) 25. Oversee, support and coordinate with Althera affiliate manufacturing and Testing sites and the RnD site. 26. Preparation, Review of the PQRs for Althera products. 27. Ensure quality / technical agreements with contract manufacturing organizations (CMOs)are available and updated within timelines. Preferred candidate profile Perks and benefits best in the industry

- Experience of Calcium Lactobionate Manufacturing - Responsible for preparing work instruction for Production and manufacturing activities - Maintain online documentation related to production activities like BMR, BPRs, logbooks and daily records. Required Candidate profile Relocation from Maharashtra only - Qualification of production equipment and participation in validation activities - Maintaining documentation such URS, DQ, IQ, OQ, PQ validation protocol with report

Role & responsibilities Follow good hygiene practices as per approved Food Safety Standards”. Management of Audit and Compliance. Prepare and Review of documents related to FSSC 22000 and its implementation. Review of SOPs in E-DMS. Review of Change control, Deviation, Incidents. Food Safety Meetings/Quality management Systems Meeting and Trainings. Preform Internal auditing and External Auditing. Provide the trainings to subordinates. To ensure the compliance of E-QMS. To prepare the document w.r.t ESG requirement. Ensuring audit coordination with coordination with customers/ regulatory/ in-House/ vendor as per schedule, audit CAPA & closure.

1.Responsible for all floor QC,QA,QMS at plant 2, Team management, systems, work instructions and SOP adherence 3.ISO FSC, Sedex, 5S Audits and compliance 4 Ensure calibration of Lab Instruments as per NABL 5. CAPA,- RCA, report & corrective steps

JD:- Creating and ensuring production quality processes/controls are in place and meet company's standards of quality Implement all relevant procedures as per ISO and company's best practices and ensure compliance. Ensuring all products adhere to quality standards Respond to customer complaints by putting in containment actions, performing a full analysis, using Quality tools , and implementing CAPA. Monitor and analyze data related to Quality Control process and Introduce new systems and procedure as needed Participate in cross-functional teams to develop and implement new products or services, ensuring that quality control processes are integrated into the development process. Ensure development and implementation of supplier qualification/evaluation/approval criteria . Work with suppliers and vendors to ensure that raw materials and components meet established quality standard Ensuring customer inspection/FAT for products Conducting Internal audit and managing external ISO audit. Ensure accuracy and implementation of Supplier Quality, Sustainability and Risk Management policies, procedures and related processes Understand, evaluate, and determine the adequacy of risk assessments, supplier qualification, supplier segmentation, controls effectiveness, monitoring frequency, governance and business reviews of suppliers Report of supplier performance and risk mgmt measures incl. supplier auditing, qualification, certification Implement and follow evaluation and performance measurement tool/system. Prepare reports for and report out monthly/quarterly on supplier performance, risks and issues Deploy operational excellence initiatives in collaboration with other functions. Create and execute supplier remediation plans jointly with category mgmt. Motivate and coach team on quality and operational KPI Delivery. Own development of Quality team Part of India Management team and contribute to operational excellence Interested candidates kindly share your cv to hr38@hectorandstreak.com

Key Responsibilities: Implement and maintain Quality Management Systems (QMS) in compliance with IATF 16949, ISO 9001, and other regulatory standards. Conduct internal and external quality audits , prepare audit reports, and ensure timely closure of non-conformities. Monitor and analyze quality KPIs , drive corrective and preventive actions (CAPA), and ensure continual improvement. Develop and update standard operating procedures (SOPs), control plans, FMEAs, and other quality documentation . Coordinate with cross-functional teams (Production, Supplier Quality, and R&D) to resolve quality issues. Handle customer complaints, root cause analysis (RCA), and implementation of corrective actions using quality tools like 8D, 5 Why, and Fishbone analysis . Work closely with suppliers to ensure supplier quality assurance (SQA) and compliance with QMS requirements. Lead training and awareness programs related to QMS, audits, and quality improvements. Support new product development (NPD) and ensure alignment with quality standards.

1. Running Improvement projects that improve line quality performance to ensure that each process stage operates at a high process capability. 2. Identifying projects to improve the quality of component used on the line. 3. Deploy simplified and robust processes in manufacturing to achieve zero defect (> 2Cpk process). 4. Improve productivity (output/head) and production (above rated capacity) 5. Reduce direct cost (material and labour) 6. Eliminate the need of Repairing 7. Become proficient in the use of Shainin Technique and engage line supervisors/shift in charges in this technique.

1. Responsible for reviewing, approving and distributing work instruction for manufacturing activities. 2. Carry out production activities as per production plan. 3. Review online documentation related to production activities BMR, BPRs, logbooks

Creation/modification of process flows within the Manufacturing/Service Departments. Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. Perform gap assessment and conduct remediation of documents with stakeholder inputs. Development and maintenance Manufacturing/Service Work Instructions and related documents. Creation/modification of fixtures, tooling, equipment and systems to support operations. IQ, OQ, and PQ of fixtures, tooling, and equipment. Identify, investigate, and resolve operational issues to improve First Pass Yield and reduce waste. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred. Must be able to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment. Experience with statistical software packages (Minitab is a plus), SAP, windchill, onePLM etc. Experience with Quality Systems and process controls in the medical device industry is desirable. Knowledge and working application of FDA, cGMP, ANSI/ISO/ASQC requirements. Knowledge and working application of technical part drawings and GD&T principles. Demonstrated application of engineering principles on individual/small projects and ability to work with cross functional teams to successfully implement quality improvement and cost reduction initiatives. Demonstrated strong analytical problem solving Root Cause Investigations, CAPA, Six Sigma, continuous improvement projects. Ability to multi-task and methodically lead/manage projects. Location: Chennai Required Skillset: Gap Assessment and Remediation for DMR, Class 2 and 3 device

Job Title: Assistant Manager Operations Location: Chennai, India Department: Operations Reports To: Operations Manager Job Summary: We are seeking a highly skilled and experienced Assistant Manager Operations to join our team in Chennai. The ideal candidate will have a strong background in people management, communication, data analysis, SLA adherence, error management, innovation, strategic thinking, and stakeholder management. The role requires a proactive and strategic thinker with the ability to align team objectives with business goals and drive operational excellence. Key Responsibilities: People Management: Manage a team, discuss performance, and provide constructive feedback. Successfully motivate the team and resolve conflicts effectively. Communication Skills: Clearly articulate thoughts in both verbal and written communication. Regularly provide transparent updates to teams and stakeholders. Data & Reporting Proficiency: Analyze performance metrics and provide feedback based on data. Work with forecasting, overtime analysis, and performance tracking. Translate data insights into actionable recommendations for decision-making. SLA & Service Delivery: Ensure adherence to SLAs and monitor service performance. Proactively identify risks and implement measures to ensure on-time delivery. Error Management: Conduct Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA). Track and report quality metrics such as error rates or rework percentages. Innovation & Project Contribution: Lead or contribute to projects that improve team productivity or business outcomes. Proactive Actions & Results: Take initiative to anticipate challenges and drive team efficiency. Strategic Thinking & Business Acumen: Align team objectives with business goals to drive growth. Adapt strategies based on market trends and business needs. Stakeholder Management: Build strong relationships with clients, vendors, and leadership to ensure successful outcomes. Change Management: Lead the team through organizational changes while maintaining productivity. Qualifications: Bachelors degree in Business Administration, Operations Management, or related field. Proven experience in managing operations and a team. Strong data analysis and reporting skills. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and manage multiple tasks. Strong problem-solving and decision-making abilities. Knowledge of SLA management, error management, and process improvement. Skills Required: People Management Communication Skills Data & Reporting Proficiency SLA & Service Delivery Error Management Innovation & Project Contribution Proactive Actions & Results Strategic Thinking & Business Acumen Stakeholder Management Change Management Benefits: Competitive salary package Health and wellness benefits Professional development opportunities Collaborative and inclusive work environment Opportunity to work with leading industry professionals

Role & responsibilities You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables: 1. Ensure manufacturing practices as per cGMP and GLP standards. 2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc. 3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) 4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits. 5. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG) 6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers. 7. Assisting HOD in customer complaint analysis and preparation of customer complaint report. 8. Investigation of incidents, deviations, OOS and ensure corrective actions in place. 9. Reviewing the daily availability of operators and allocating work to them. 10. Maintaining and review BMR documents, guide for relevant changes if required. 11. Label artwork review and management. Technical Competencies: a) Analytical skills (spotting trends and patterns) b) Report writing skills c) Problem solving abilities d) GMP and GDP knowledge e) Good English communication skills (verbal & written). Behavioural Competencies: a) Quality and Service Orientation b) Delivering consistent results c) Ability to prioritize, organize, manage work and time. d) Customer Centric e) Cross Functional Team Working Preferred candidate profile B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology) 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries. Perks and benefits 1. Opportunity to be part of a growing organization offering niche products to Pharma industry. 2. Opportunity to work at Head Office location. 3. Intimate small company culture with MNC professionalism. 4. Company value programs TrANSSCEnD. 5. Employee events like festival celebrations, family fun events etc. 6. Five days working (alternate weeks). 7. Medical Insurance for your immediate family. 8. Housing accommodation for Bachelors & family.

To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers. To review the process validation/ cleaning validation qualification protocols. To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products. To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety Quality management system. To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program. To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically. To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of Food safety standards (FSS) act and other legal, customer and regulatory requirements. To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non-conformities observed during the audits. To ensure compliance to the current ISO 9001, DC Act, FSS Act 2006, FSSC 22000 (including HACCP), FAMI-QS, WHO-GMP and other customer and regulatory requirements. To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility. To ensure completion of APRs of products and take appropriate actions in case of deviations. Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods. Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition. To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site. To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures. To identify and provide resources with co-ordination with other departments to carry out quality functions effectively. To liaison with regulatory authority for new product permissions, licenses and renewals, certificates, and approvals. Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 110 111. Ensuring avoidance of breach of data integrity at all the levels. Ensuring implementation of effective sanitation activities at all the levels. Imparting required training to shop floor personnel. Adherence to the requirements of EHS norms. To raise the PR for procurement of miscellaneous items, external trainings, certification fees and capex related items. To sign the Excess Material Requisition, LRA notes, BMR return notes and other QMS documents in absence of Head- QA. To perform MSC2N transactions in SAP. Review of Change Control, Deviation, CAPA in trackwise. Implementation and execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset). SOP, BMR/BPR, layouts, STP review and approval in ENSUR system. To conduct vendor audits for RM/PM. To lead and guide the IPQA team for shopfloor activities. To set, review and evaluate KRA of reportee s. To share the RR nominations of team members on quarterly basis. To identify and implement the OE projects. Patient/ Customer centricity. B. Pharm/ M. Pharm

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : PySpark Good to have skills : Python (Programming Language) Minimum 3 year(s) of experience is required Educational Qualification : Must have minimum 15years of full time education Summary : As an Application Developer, you will be responsible for designing, building, and configuring applications to meet business process and application requirements using PySpark. Your typical day will involve working with Python, developing and configuring applications, and collaborating with cross-functional teams to ensure successful project delivery. Roles & Responsibilities: - Design, build, and configure applications to meet business process and application requirements using PySpark. - Collaborate with cross-functional teams to ensure successful project delivery. - Develop and configure applications using Python programming language. - Troubleshoot and debug applications to optimize performance and ensure data integrity. - Stay updated with the latest advancements in PySpark and Python programming language. Professional & Technical Skills: - Must To Have Skills:Proficiency in PySpark. - Good To Have Skills:Proficiency in Python programming language. - Strong understanding of application development and configuration. - Experience with troubleshooting and debugging applications. - Solid grasp of data integrity and security best practices. Additional Information: - The candidate should have a minimum of 3 years of experience in PySpark. - The ideal candidate will possess a strong educational background in computer science or a related field, along with a proven track record of delivering impactful data-driven solutions. - This position is based at our Bengaluru office. Qualifications Must have minimum 15years of full time education

Key Responsibilities: Plan, organize, and oversee daily production operations to meet targets. Ensure optimal resource utilization , including manpower, machinery, and materials. Monitor production KPIs such as cycle time, OEE (Overall Equipment Effectiveness), and defect rates. Implement Lean Manufacturing, Kaizen, 5S, and Six Sigma methodologies for continuous improvement. Ensure strict adherence to ISO/IATF 16949 quality standards and customer requirements. Troubleshoot production issues and drive root cause analysis (RCA) & corrective/preventive actions (CAPA) . Collaborate with quality, maintenance, and supply chain teams to ensure smooth operations. Drive cost reduction initiatives without compromising quality and efficiency. Ensure safety compliance and adherence to environmental & legal regulations . Lead and mentor the production team to enhance skills and performance.

Key Responsibilities: Oversee in-process quality control and ensure adherence to approved standards. Conduct process approvals and validate manufacturing operations. Perform root cause analysis (RCA) & corrective/preventive actions (CAPA) for quality issues. Utilize 7QC tools for data analysis and problem-solving. Develop and maintain PFMEA, control plans, and standard work procedures . Ensure accuracy in Measurement System Analysis (MSA) & Statistical Process Control (SPC) . Implement process improvements to reduce defects and enhance quality . Collaborate with cross-functional teams to drive quality initiatives. Monitor supplier quality and support audits as per ISO/IATF 16949 standards. Maintain detailed documentation and reporting for quality performance metrics.

Key Responsibilities: Conduct in-process & final inspections to ensure product quality. Implement and monitor quality control processes in manufacturing. Perform root cause analysis (RCA) & corrective actions (CAPA) for quality issues. Ensure compliance with ISO/TS 16949, IATF 16949, and other automotive quality standards . Coordinate with production and design teams to resolve quality concerns. Conduct supplier quality audits and implement improvements. Monitor and analyze PPAP, SPC, and FMEA documentation. Handle customer complaints and ensure effective problem-solving techniques . Work on continuous improvement & lean manufacturing practices to reduce defects.

Preparation and review of SOPs, BMR/BPR. To process Change control and Deviations. Proficient in handling Track wise To initiate Change Control, CAPA, Deviation, Risk assessment, Market complaint, Investigation To update and maintain Index of SOPs and Formats. To issue & Retrieve Logbooks, Formats etc. To assist in compliance for internal and external audits On line training module knowledge. Should have good knowledge & proficiency in Computer. Must have worked in QMS of reputed Pharmaceutical industry Awareness of internal and external audit dealing is required Regulatory plant experience

In-Process Quality Assurance During Production Activity Including Line Clearance And Sampling At Different Stages Of Processing/Packing As Per Pharma API Review of Master Documents such As BMR / BPR Test Batch Monitoring Process Validation Protocol Required Candidate profile Experience with reputed API or Bulk Drugs Unit Co-Ordinate with Plant QA And RA for PDR related activities To Review Specification, MOA And Analytical Data Good Computer And Communication skill Etc

Ensure product quality and regulatory compliance (MDR, QMS). Assist in SOPs, audits, documentation, and ISO 13485:2016 compliance. Support QC, microbiological testing, complaints, training, and regulatory updates. Required Candidate profile Experience in ISO 13485:2016, cGMP, EU MDR 2017/745, documentation, QA, and audits. Knowledge of microbiological testing, lab maintenance, compliance, problem-solving, and strong communication.

Leading BPO in Bangalore Hiring for Transactional Quality Manager International Banking Voice Process Must be a Manager Quality On papers in an International BPO in Banking Process(Voice) Over All Experience 8+ Years CTC UPTO 19LPA based on Last CTC & experience Interested candidates can mail their cv at simmi@hiresquad.in or call at 8467054123 Role & responsibilities Analytical mindset to drive continuous improvement for key CTQs (i,e, NPS / CSAT / FCR) Manage Call Quality & Client related KPI's with analytical quantification and establish co-relation Evaluate effectiveness of TQ interventions. Strengthen Quality management processes / framework to improve quality delivery. Drive Process control & Compliance in addition to managing the Audit requirements. Ensure knowledge consistency through calibration, quizzes, D-Sat scrubbing etc. Interact and streamline channels of communication with other Functions and Clients. Provide quality floor support, feedback, refresher and corrective training Support cross process / location teams. Support the Quality and Compliance teams to perform audits and follow ups based on observations highlighted. Key skills & knowledge: Graduate in any discipline Green Belt Trained and Certified Good Knowledge about computers. Excellent communication skills. Good people management skills Good knowledge of MS Office Analytical / Quantitative skills Maturity in handling customers and work in a multi culture process environment Data Handling / data interpretation Good working knowledge of T&TQ (Training & Transaction Quality) systems, tools and technologies. High level of maturity to handle people including but not limited to client, stake holders, peers etc. Process Oriented, Planning, Decision making, Data Handling, Ability to prioritize, Ability to meet deadlines and work under pressure in an unstructured environment Detail oriented with Strong organizational and Presentation skills Flexible to work in a 24X7 environment (night shifts and weekends basis scope) Ability to generate and implement out of the box ideas and Process improvement initiatives in the process. Designed the FMEA framework in the existing organization or in the past Interested candidates can mail their cv at simmi@hiresquad.in or call at 8467054123

•QMS Daily monitoring (Logging, Investigation, Closures) and logs maintenance •GLP maintenance •Data integrity •Availability of STPs & SOPs with related working documents •Responsible to ensure release of Certificate of analysis (COA).

A Quality Control (QC) job in the pharmaceutical industry involves rigorously testing and analyzing raw materials, in-process samples, and finished products at various stages of drug manufacturing to ensure they meet established quality standards.

Breakdown maintenance of CNC machines Preventive Maintenance Schedule Maintenance as per plant Requirement Root Cause analysis of breakdown in plant Spare management Manpower management Knowledge of safe practice in maintenance

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

•Collaborates with teams of engineers and product specialists. •Reviews design, manufacturing, and testing documentation •Internal audit, CAPA •QMS, 5S Kaizen on Shop floor •Experience with steel/metal industry