12 Capa Implementation Jobs

As a Procurement Manager at a leading CDMO of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry, your primary responsibilities will include: - Submitting RFQs, compiling quotation comparisons, conducting negotiations, issuing purchase orders, and actively tracking all material deliveries. - Reviewing with the planning team and monitoring purchase requests to ensure 100% On-Time In-Full deliveries. - Managing Contract Manufacturing Operations End-to-End to ensure completion of Regular as well as development campaigns. - Coordinating with all stakeholders to ensure CMO Projects are carried out smoothly without any delay, including Sales, Production, Material Vendors, Packaging Vendors, Research & Development, Quality Control, Quality Assurance, and CMO Vendor Teams. - Planning ahead for Input Materials and strategically assessing risks to ensure adequate supplies are on hand. - Maintaining close coordination with plant teams (CFTs), end users, and R&D for any rejections, as well as providing prompt support for resolving vendor-related issues/rejections and ensuring timely CAPA implementation. - Sourcing of Raw Materials, Critical/Key Starting Materials, intermediates, Solvents, R&D, QC chemicals for API Contract Research Orgn. The ideal candidate for this role should have experience in General raw materials, key raw materials, and KSM procurements for R&D Project Management/API Labs within the CDMO/CRAMS domain. Effective negotiation skills and an understanding of market dynamics to facilitate procurement at the optimal timing and price are essential. The annual compensation for this position is in the range of 15-18 LPA. For any further queries, you can reach out to Anoop Sinha, Director at PROFILE HR CONSULTANTS PVT LTD, at 9773520069.,

Oversee lab ops for raw/in-process/finished goods. Maintain HPLC/GC, ensure calibration/validation, GMP/GLP, audits, CAPA, SOPs, and ISO compliance. Skilled in QA, validation, and regulatory in chemical/agrochemical manufacturing.

You will be responsible for resolving technical issues for SGRE & Vestas fleet, providing training to Asset Management & Self O&M team, and implementing RCA & CAPA processes. Your duties will include tracking software implementation, ensuring technical clearance of major components, and conducting Factory Acceptance Tests for construction and engineering projects. You will also be tasked with finding alternative components for key parts, writing technical documentation, and implementing maintenance strategies. Additionally, you will focus on team building and mentoring to enhance technical skills for handling SGRE and Vestas turbines. You will be involved in initiating, developing, and monitoring new technologies to improve safety, reliability, and performance of SGRE projects. Your role will also include providing central technical support for material, supplier, and on-ground support for SGRE and mechanical components, as well as managing the quality of incoming spare parts.,

As a member of the ACG Packaging Materials team, your primary responsibilities will include strategic planning and analysis of customer complaints to recommend appropriate corrective and preventive actions. You will ensure compliance for updating CTQ requirements in ZMIC (SAP) to eliminate repeat complaints from critical customers, thus contributing to the avoidance of re-occurrence. Your role will also involve resolving technical issues at the customer end by providing guidance during trials and ensuring the effectiveness of action plans to avoid rejection and help in Cost of Poor Quality (COPQ) reduction. In your core functional duties, you will collect all necessary information related to customer complaints for root cause analysis, coordinate with various departments and customers for the effective implementation of Corrective and Preventive Actions (CAPA), and track the effectiveness of submitted CAPAs against customer complaints. It will be essential to maintain records and samples systematically for easy retrieval and traceability, as well as to participate in continuous improvement initiatives such as Kaizen for enhancing product quality. Internally, you will provide customer complaint analysis to relevant departments for continuous learning, coordinate with Sales for handling rejected material receipt at the factory, and ensure adherence to prescribed procedures and action plans by internal customers and suppliers. Key result areas of your role will include minimizing justified customer complaints, ensuring timely implementation of action plans and technical closure, maintaining order processing as per Sales Order and Critical to Quality (CTQ) requirements, providing necessary training to teams, and devising effective action plans to reduce COPQ in alignment with business objectives. Your key interfaces will involve collaborating with internal departments such as Planning, Production, Sales, Business Development, and external interfaces including Suppliers, Customers, Service providers, and Auditors. The desired competencies for this role include sound technical knowledge, plant quality assurance understanding, proficiency in Quality Control Tools, effective customer and supplier management, as well as demonstrating values such as being a Collaborator, Builder, Entrepreneur, Innovator, Integrator, Nurturer, and Partner. Overall, your role will be crucial in ensuring customer satisfaction, quality improvement, and operational excellence through proactive analysis, coordination, and implementation of corrective actions to address customer complaints effectively.,

We are seeking skilled and dedicated individuals to join our Quality Assurance (QA) department at Fido Pharma Private Limited, an esteemed pharmaceutical company located at Plot No: 108-109, Global Industrial Park, Mauli, Barwala, Panchkula, Haryana. If you have a background in B.Pharm / M.Pharm / M.Sc. and a passion for ensuring quality in pharmaceutical products, we have the following positions available: QA Manager: As a QA Manager, you will lead our Quality Assurance department, overseeing adherence to GMP and regulatory guidelines such as EU-GMP and WHO-GMP. Your responsibilities will include managing document control, validations, change control, Vendor Qualification, CAPA, deviations, and internal and external audits. You will be the main point of contact with regulatory bodies during inspections, ensuring timely compliance. Additionally, you will be responsible for developing and maintaining the company's quality systems and risk management strategy. Strong knowledge of cGMP, ICH, and regulatory requirements is essential for this role. Excellent communication, team management, and problem-solving skills are required. Previous experience in regulated manufacturing environments is preferred. Assistant Manager - Quality Assurance: In the role of Assistant Manager, you will provide support in managing and executing the site's quality systems, including change control, deviation handling, market complaints, and CAPA monitoring. You will assist in conducting periodic quality reviews and risk assessments and review batch documentation for accuracy and completeness. Internal audits, compliance activities, training sessions, and vendor qualification processes will also be among your responsibilities. A background in B.Pharm / M.Pharm / M.Sc. and 5-10 years of relevant experience are required for this role. Executive - Quality Assurance: As an Executive in the Quality Assurance department, you will be involved in line clearance and in-process quality assurance activities. Your duties will include maintaining documentation, supporting regulatory compliance, conducting internal audits, and assisting in vendor qualification processes. You will also participate in investigations of deviations, training programs, and vendor audits. Reviewing executed BMRs/BPRs, process control charts, and release documents will be part of your daily tasks. A background in B.Pharm / M.Pharm / M.Sc. and at least 1-6 years of experience are necessary for this role. If you are detail-oriented, proactive, and passionate about ensuring quality standards in the pharmaceutical industry, we invite you to apply for one of these exciting positions at Fido Pharma Private Limited. Join our team and contribute to the continual improvement of our quality systems and processes.,

As a Lead - Safety, Health & Environment (SHE) based in Hyderabad, your main responsibility will be to drive safety initiatives, ensure compliance with regulations, and promote environmental sustainability at our site operations. Your leadership is crucial in upholding our commitment to zero accidents and fostering a strong safety culture within the facility. In this role, you will be expected to lead the implementation of safety measures, including conducting Job Safety Analysis (JSA) for high-risk operations, promoting a near-miss reporting culture, and conducting regular safety inspections and toolbox talks to enhance accident prevention awareness. Your goal will be to achieve zero accidents and dangerous occurrences by effectively managing risk and implementing safety practices. Legal compliance and documentation will also be a key aspect of your role. You will need to develop and maintain procedures to ensure compliance with legal requirements from regulatory bodies such as the Pollution Control Board and PESO. Additionally, you will be responsible for maintaining documentation of all legal licenses, agreements, and compliance records, as well as coordinating the timely renewal of licenses with the Corporate Legal Affairs team. Your role will also involve driving the implementation and maintenance of ISO standards for Environmental, Occupational Health & Safety, and Energy Management at the site level. You will manage the Environmental Safety System (ESS) online platform for incident tracking and monitoring, update work permit procedures, and develop Emergency Preparedness and Response plans. Collaboration with cross-functional teams will be necessary to achieve SHE and sustainability objectives at the site level. You will drive initiatives related to energy conservation, renewable energy adoption, water conservation, and waste reduction programs. Additionally, you will be responsible for coordinating with waste treatment and disposal parties for site-generated waste and preparing environmental agreements in coordination with the Corporate Legal team. In terms of performance management and reporting, you will lead monthly Business Unit APEX meetings, investigate incidents, and implement Corrective and Preventive Actions (CAPA) for all incidents. Your goal will be to ensure continuous improvement in site safety standards and practices through effective communication, coordination, and leadership. To qualify for this role, you should have a Bachelor's degree in Engineering, Environmental Science, or a related field, along with 15-20 years of experience in Safety, Health & Environment management. A professional certification in Safety Management (such as NEBOSH or IOSH) and strong knowledge of ISO standards are required. Experience with legal compliance, incident investigation, and team leadership will be beneficial, as well as proficiency in safety management systems. Preferred qualifications include a Master's degree in Occupational Health & Safety or Environmental Management, experience in manufacturing or industrial site operations, knowledge of risk assessment methodologies, emergency response planning, and coordination with legal affairs and external consultants. Your role will be critical in ensuring the safety, health, and environmental sustainability of our site operations in Hyderabad.,

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording temperature and humidity in the laboratory area, and managing document control. The ideal candidate should possess skills in audit trial, OOT, deviation handling, OOS, backup and restoration data management, sample handling, instrument maintenance, quality assurance, instrument calibration, laboratory practice, laboratory incidents management, change control, method edit forms, working standards review, analytical records analysis, quality control, document management, equipment qualification, stability protocols, analyst qualification, analytical method validation, CAPA implementation, and temperature monitoring.,

As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and quality risk management activities, conducting self-inspections, and supporting external/internal audits. You will review and approve SOPs, protocols, and reports related to validation, qualification, and quality systems, monitor and support validation activities, oversee document control, ensure timely closure of audit observations and CAPA implementation, and coordinate with various departments to ensure overall GMP compliance. Additionally, you will participate in training programs and provide QA training to cross-functional teams. SAVA Healthcare Limited (SHL) is a diversified pharmaceutical company committed to delivering quality-driven pharmaceutical solutions globally. Established in 2003, SHL has a strong presence in International Business, Animal Healthcare, Herbal Products, and Contract Research & Manufacturing Services (CRAMS). The ideal candidate for this role should have a B.Pharm / M.Pharm / M.Sc. degree with 4 to 7 years of experience in QA in a regulated pharmaceutical formulation plant. You should possess a strong understanding of GMP guidelines, quality systems, validation practices, and regulatory audits. If you are passionate about maintaining high-quality standards, ensuring regulatory compliance, and contributing to the success of a leading pharmaceutical company, we encourage you to apply for this exciting opportunity at SAVA Healthcare Limited, Surendranagar Plant, Gujarat.,

As the Manager Quality in the Spinning Unit located in Edlapadu, your primary responsibility will be to oversee and lead the quality function of a large spinning unit with 100,000 spindles. Your role will be crucial in ensuring the consistent delivery of high-quality yarn for both local and export markets while focusing on achieving superior yarn quality, addressing customer feedback, and upholding compliance with social and sustainability standards. Your key responsibilities will include ensuring adherence to specified quality parameters for various types of yarn such as combed warp, hosiery counts, dyed packages, core-spandex, slub yarns, and export-grade yarns. You will be required to monitor and analyze daily quality test results, promptly identify deviations, and implement necessary corrective actions to maintain optimal yarn realization and minimize wastage through effective process control. Collaboration with production and maintenance teams will be essential to uphold the required quality standards and develop suitable cotton mixing parameters based on product requirements. Your role will demand a comprehensive understanding of medium and fine cotton yarn counts, hands-on experience with machinery such as KTTM, Trtzschler, and LMW, as well as the ability to comprehend key maintenance schedules and their impact on product quality. Efficiently handling customer feedback, implementing Corrective and Preventive Actions (CAPA), and ensuring customer satisfaction by meeting product quality expectations will be integral to your duties. You will also lead social and sustainability compliance audits including GOTS, OCS, BCI, Regenagri, Oeko-Tex, Inditex, and GCC, maintaining all necessary records and documentation for certifications and audits. In terms of skills and competencies, you should possess strong analytical and problem-solving abilities, excellent interpersonal and team coordination skills, proficiency in computer applications like Excel and ERP systems, in-depth knowledge of cotton yarn manufacturing and quality systems, and the capability to collaborate effectively with cross-functional teams. The ideal candidate for this role should hold a Diploma/Degree in Textile Technology or a relevant field and have a minimum of 10-15 years of experience in managing quality in large spinning units with a minimum of 100,000 spindles. Familiarity with both domestic and export yarn quality standards will be advantageous. If you believe you possess the requisite qualifications and experience for this role, please share your resume at jigisha.m@nsltextiles.com.,

As a Validation Specialist at Piramal Pharma Solutions, your primary responsibility will involve preparing and updating various validation documents to ensure compliance with regulatory requirements. This includes developing Validation Master Plans (VMP), Process Validation protocols, Computer System Validation protocols, and reports. You will also be responsible for creating product matrices, Cleaning Validation/Verification protocols, qualification/requalification protocols for equipment/instruments, utilities, and facilities, as well as area validation protocols and reports. In addition to validation activities, you will be involved in quality risk assessments, review of calibration certificates, issuance and archival of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR), preparation of Annual Product Quality Review (APQR), line clearance for manufacturing, packing, and dispensing activities, sampling of bulk and finished goods, and review of production records. Furthermore, you will play a key role in managing change controls, deviations, and CAPA (Corrective and Preventive Actions), conducting complaint handling, updating departmental SOPs, providing training as per schedule, coordinating training programs with HR, and ensuring documentation management as per SOP. You will also be responsible for providing necessary documents/data to meet internal and external quality, environmental, health, and safety requirements. Moreover, you will be involved in compliance monitoring through self-inspection programs, audit compliance coordination, preparation of responses to audit reports, and execution of food/dietary supplements regulations for export markets. You will also oversee the implementation of sanitation programs, adherence to EHS norms, and various corporate initiatives. Piramal Group values equal employment opportunity, ensuring that all applicants and employees are treated fairly based on merit, qualifications, skills, and performance. As part of a globally integrated network of facilities, Piramal Pharma Solutions offers a wide range of services across the drug life cycle, making it a trusted partner for innovators and generic companies worldwide.,

You are dedicated to enhancing daily living through innovative, ergonomic solutions that promote comfort and well-being. Your mission is to design the next generation of products to empower people to walk, sit, and sleep better. Each product you create is fueled by the same passion that drove you to innovate from day one: to give people the freedom to do more. Join the mission to transform everyday struggles into freedom and joy. Discover Frido and experience the freedom to live life your way. You are seeking a skilled and experienced Production Engineer to oversee the manufacturing process of polyurethane memory foam products. The ideal candidate will have a deep understanding of polyurethane foam production techniques, quality control measures, and operational efficiency. You will be responsible for leading a team, optimizing production schedules, and ensuring product quality meets or exceeds industry standards. Responsibilities include: - Production Oversight: Manage day-to-day operations of the polyurethane foam production facility, ensuring production targets are met while maintaining high standards of quality and safety. Implement strategies to optimize production processes, minimize waste, monitor production metrics, and report on KPIs. - Team Leadership: Lead and motivate a team of production staff, including supervisors and operators. Provide training and guidance to all team members, foster a culture of continuous improvement and teamwork. - Inventory Management: Coordinate with the supply chain and procurement teams to ensure adequate inventory of raw materials and supplies. Optimize inventory levels to minimize stockouts and excess inventory. - Safety Compliance: Enforce safety protocols and procedures to ensure a safe working environment for all employees. Conduct regular safety inspections and training sessions. Investigate and report any accidents or incidents and implement preventive measures. - Budget Management: Develop and manage the production budget, including labor, materials, and overhead costs. Identify opportunities to reduce costs and improve efficiency without compromising quality. - Continuous Improvement: Drive continuous improvement initiatives to enhance productivity and quality. Collaborate with cross-functional teams to implement best practices and innovative solutions. Qualifications: - Bachelor's degree in Engineering, Manufacturing, or a related field (preferred). - Proven experience in polyurethane foam production, expertise in memory foam production is desirable. - Strong leadership and management skills with the ability to inspire and motivate teams. - Excellent problem-solving abilities and attention to detail. - Sound knowledge of production planning, scheduling, and inventory management. - Familiarity with quality management systems and regulatory standards. - Proficiency in MS Office and CAPA implementation. Experience in the Audit of ISO 9001:2015. - Effective communication and interpersonal skills. If you are interested in this position, please send your CV to ruchi.c@myfrido.com along with details of your Current CTC and Notice Period.,

Job Description: As a member of the team, you will be responsible for identifying, reviewing, and implementing Pharmacopeial updates on a global scale. This will involve conducting activities related to the revision of product specifications and methods through a change management process. You will also be required to assess the impact of changes and review updates to ISO Guidelines. Additionally, you will collaborate with various departments to ensure compliance with USP/NF or other Pharmacopeial standards and ISO Guidelines. Regular reporting of work completion status to the reporting manager and coordination with them for updates to the management will be essential tasks. You will also be involved in preparing quality metrics, conducting risk assessments related to the Compendial Review Team, and ensuring compliance with the QMS system. Furthermore, your role will include the preparation, review, and implementation of common SOPs, procedures, and policies. Your educational background should include an M.Pharmacy/M.Sc degree, along with a minimum of 6 to 8 years of experience in QC/QC reviewer/QA (GMP). This position requires strong attention to detail, excellent communication skills, and the ability to work effectively in a dynamic and regulated environment. If you are passionate about ensuring quality and compliance in pharmaceutical processes, this role will provide you with the opportunity to make a significant impact in the industry.,