7 Capa Management Jobs

Date: 21 Jun 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Description Job Title: Lead Manufacturing Operations -OSD Job Location: Biocon Park, Bengaluru Department: Drug Product Manufacturing About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned. Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards. Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace always. Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self. Compliance to Syngene s quality standards always Hold self and their teams accountable for the achievement of safety goals. Govern and Review safety metrics from time to time. Core Purpose of the Role: The primary purpose of this role is to ensure the highest standards of manufacturing compliance and quality for Oral Solids (tablets, pellets, capsules, liquid-filled capsules at Syngene International Limited. This encompasses the management of regulatory audits and overseeing Corrective and Preventive Actions (CAPA) to drive continuous improvement. This role is essential for ensuring operational excellence, regulatory adherence, and the delivery of high-quality pharmaceutical products, ultimately contributing to Syngene International Limiteds commitment to patient safety and industry leadership. Role Accountabilities Responsible for ensuring that all the Oral solids manufacturing & packaging is all time audit ready and in compliance with cGMP and regulatory expectations from USFDA, EU, MHRA, Health Canada. Management of QMS documentation as a part of review process of change controls, deviations, investigations, CAPA, OOS, OOT, Customer compliant, APQR, validation protocols, study protocols etc. Actively review the implementation of Quality Management System (QMS) within the function to ensure that processing activities are being conducted in accordance with QMS requirements as well as current regulatory and quality standards. To drive high impact projects on cost saving, process improvement at Development and manufacturing, Support for working on annual Capex & Open requirements & all the operations are run-in cost-effective manner. To review facility capacity and equipment feasibility with respect to rolling plan and new product requirement and to initiate proposals for procurement of new equipment, facility upgradation and expansion. Document management for review of URS, DQ, IQ, OQ and, PQ of equipments/ instruments etc. as a reviewer. Responsible for improving the efficiency and effectiveness of business operations by identifying and implementing process. Co-ordination with cross functional teams to ensure facility is in state of compliance and to meet production targets. Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards. Govern and Review safety metrics from time-to-time following environment, health, and safety (EHS) requirements always in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all team members. Leadership Capabilities Proficient in managing multiple projects simultaneously. Strong problem-solving skills to address compliance issues swiftly and effectively. Ability to lead and motivate cross-functional teams. Foster a collaborative environment that encourages open communication and accountability. Drives Performance against outcomes. Syngene Values All employees will consistently demonstrate alignment with our core values. Excellence Integrity Professionalism Accountabilities As a Syngene Leader (only For Leadership Hires) Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority. Specific Requirements For This Role Experience: Having experience of more than 18 years in manufacturing operations in oral solids. Having experience in injectable will be an added advantage in global pharmaceutical companies. Skills And Capabilities Regulatory Audits from FDA, EMEA, Health Canada. To participate in periodic management review meetings, self-inspections, and internal quality audit. Expertise in conducting thorough investigations, CAPA management, OOS. Strong analytical capabilities to assess compliance data and identify trends. Proficient in Oral Solids product manufacturing and process troubleshooting. To be part of QRM assessment, BMR, BPR, artwork review. Expertise in Injectable manufacturing will be an added advantage. Education: Postgraduate in pharmacy Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status regarding public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

The Quality Lead position at ProPharma involves driving positive change and process improvement in the assigned region. This role serves as an independent and objective entity, supporting various operational teams and performing quality activities as per ProPharma Group's Quality Policy and procedures. The Quality Lead is responsible for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Developing, managing, and executing quality management processes to ensure compliance with regulatory requirements is a key aspect of this role. Essential Functions: - Maintaining awareness of and ensuring adherence to applicable SOPs/controlled documents, regulations, guidelines, and client agreements. - Serving as a control point for SOPs/controlled documents and Quality Management System documents. - Contributing to the creation of controlled documents such as SOPs and Work Instructions. - Supporting the internal quality program including quality assurance and quality control. - Assisting in investigating service complaints and deviations, identifying root cause and CAPAs, and communicating these to the Managers. - Collaborating with Operational and Client Services Managers to support preparation for client audits and regulatory inspections. - Hosting client audits and regulatory inspections at ProPharma Group and acting as an SME for quality topics. - Developing responses to CAPAs arising from client audits and regulatory inspections, with support from Operations Managers, Client Services, and Global Quality, and tracking to completion and closure. - Participating in relevant client operational meetings as directed by Management. - Supporting the Quality Manager in the Regional Quality Committee and acting as a regional representative in the Global Quality Committee. - Proactively identifying improvement opportunities to support the development of ProPharma Group as a leading provider of outsourced global Medical Information solutions. - Identifying any issues that could potentially impact services and escalating areas of concern within the business to Management, with potential corrective actions. - Other responsibilities as assigned. Necessary Skills & Abilities: - Excellent attention to detail and focus on quality. - Strong verbal and written communication skills. - Excellent workload management skills. - Ability to prioritize workload and meet deadlines. - Excellent questioning and listening skills. - Capable of resolving conflict constructively. - Able to collaborate with colleagues in other departments effectively. - Ability to speak effectively in interpersonal situations and presentations. - Possesses a service-oriented approach. - Flexible and proactive toward changing needs. - Good understanding of quality assurance regulations and guidelines, preferably related to cGxP. - Quality Assurance experience in internal and external audits, maintaining regulated documents, and training files, preferably related to cGxP. - Knowledge of FDA regulations for adverse event and product complaint reporting. - Proficiency in MS Word, Excel, and PowerPoint. Educational Requirements: - University/Bachelor's degree and/or appropriate relevant work experience. Experience Required: - 5 years Quality experience in pharmaceutical or medical device industries or other regulated industry. - Previous experience in data mining, analysis, and presentation. - Previous audit experience preferred. ProPharma Group is committed to diversity, equity, and inclusion, creating a workplace where employees can be their authentic selves and are encouraged to be innovative and collaborative. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. Please note that ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Phone calls or emails regarding this posting are not accepted.,

As a Senior Executive/ Assistant Manager in the Corporate Quality Assurance Pharmacovigilance department, located in Kandivali - West, Mumbai, your primary responsibility will be to ensure compliance with SOPs of the Corporate Pharmacovigilance cell and Corporate Quality Assurance. You will be expected to assist the Corporate pharmacovigilance cell in overseeing vendor compliance through periodic reviews and vendor audits. In this role, you will act as a liaison with internal and external auditors, taking responsibility for ensuring corrective actions are implemented according to their specifications. Your duties will also include persuading Corporate pharmacovigilance cell staff to adopt and incorporate quality methods into their work processes. As part of your responsibilities, you will be required to conduct internal pharmacovigilance audits, perform CAPA management, and review the change control process, deviations, and related Quality Management System (QMS) documents. Additionally, the role involves travel for conducting audits at corporate offices and various plants. The ideal candidate for this position should hold an M Pharm qualification and possess 4 to 6 years of relevant experience in the field. Effective communication skills, attention to detail, and the ability to work collaboratively with internal and external stakeholders are crucial for success in this role.,

The Manager-II in the MSTG department at Dadra is responsible for providing support in the execution and monitoring of trial, scale up, and exhibit process qualification batches. This includes preparing and reviewing new product documents such as material requirement sheets, master formula cards, bill of materials, risk assessment reports, sampling protocols, reports, exhibit batch manufacturing records, and exhibit protocols. Additionally, the role involves sharing process knowledge with cross-functional departments through presentations to facilitate smooth technology transfer. The Manager-II will also be involved in reviewing and evaluating product history and process parameters for technical remediation and product robustness improvement. They will prepare and submit investigation reports for Out of Specification (OOS), Out of Trend (OOT), and any failures during exhibit/validation/commercial batch manufacturing and stability testing. Tracking activities related to change control, Corrective and Preventive Actions (CAPA), planned deviations, and unplanned deviations is also part of the job responsibilities. Furthermore, the Manager-II will be responsible for preparing and reviewing product containment approaches and risk assessments for new products. This includes risk assessment reports for elemental impurities, Nitrosamine impurities, and residual solvents. The role also involves arranging placebos for quality control testing, change part development, and assessing the feasibility of products. Statistical evaluations for process assessments, preparation and review of standard operating procedures, training schedules, and conducting training sessions are also essential tasks. Lastly, the Manager-II will participate in various regulatory audits to support the plant and ensure compliance with regulatory requirements.,

As a Quality Operations Support at Sandoz, your major accountability is to adhere to the current GxP and compliance requirements while delivering quality operations to ensure product quality compliance and regulatory workflows. You will be responsible for ensuring compliance to Sandoz quality standards, relevant regulatory requirements, filed product quality standards, and service level agreements. Additionally, you will support the implementation of service quality and process improvement projects, as well as CAPA management within GQSI. It is crucial to comply with internal functional requirements, including KPI reporting, ticket management tools, and other internal procedures and processes. Regular communication with customers and partners to collect feedback on support services and report deliverables is a key aspect of your role. Focus on completing all relevant and assigned trainings in a timely manner to enhance your skills and knowledge. As you progress in this role, it is important to learn and develop an understanding to generate insights through data and digital means. Taking responsibility and ownership of assigned tasks, ensuring accuracy, and timeliness of deliverables is essential. You will be required to manage accounts in workflow applications such as SAP, GxQEM, CONDOR, ESOPs, TrackWise, etc., to ensure the appropriate execution of service deliverables. Furthermore, you will generate and analyze predefined and ad-hoc reports in various applications like Trackwise, GxQEM, etc., and take follow-up actions as needed. Joining Sandoz means becoming part of the backbone of the global medicines industry. Sandoz, a leader in generic and biosimilar medicines, has impacted the lives of almost 500 million patients last year. With a commitment to doing more, Sandoz is investing in new development capabilities, state-of-the-art production sites, acquisitions, and partnerships to shape the future and provide more patients with access to low-cost, high-quality medicines sustainably. At Sandoz, you will experience an open, collaborative culture driven by talented and ambitious colleagues. You will have the opportunity to work in an agile and collegiate environment with impactful, flexible-hybrid careers. Diversity is welcomed, and personal growth is encouraged, enabling you to shape the future of Sandoz and make a difference in the lives of patients worldwide. Embrace the momentum and entrepreneurial spirit at Sandoz as we shape the future together.,

We are looking for a meticulous and experienced Technology Transfer Manager to spearhead the efficient transfer of technology for solid dosage forms at Evertogen Life Sciences . This pivotal role involves overseeing the seamless transition of OSD products from R&D or third-party development to our manufacturing plant, ensuring successful scale-up, unwavering regulatory compliance, and adherence to the highest quality standards. The ideal candidate will champion the preparation and review of critical technical documents, including technology transfer protocols, BMR/BPR, and process validation reports, while actively coordinating with cross-functional teams such as QA, QC, RA, and Production. This role demands a proactive individual adept at troubleshooting technical challenges, participating in scale-up batches, and driving continuous improvement initiatives. If you are passionate about optimizing pharmaceutical manufacturing processes, possess a strong understanding of QbD principles, and thrive in a collaborative environment, we encourage you to bring your expertise to Evertogen and contribute to our mission of delivering high-quality, affordable medications to the global market. Your contributions will directly impact our ability to meet client needs and maintain a diverse product portfolio. Job Details: Industry : OSD Formulation (Pharmaceuticals) Department : Technical Transfer Role : Assistant Manager Tech Transfer Location : Jadcherla Compensation : Up to 15 LPA Experience : 8+ years Employment Type : Full-time Qualification : M.Pharm / B.Pharm / M.Sc. in Pharma or related field Responsibilities: Technology Transfer Execution & Documentation: Lead technology transfer projects for solid dosage forms, ensuring adherence to timelines and quality standards. Develop technology transfer protocols covering critical process parameters and quality attributes. Oversee preparation and review of essential documentation (Technology Transfer Plans, Gap Analysis Reports, Process Flow Diagrams, BMR, BPR, Process Validation Reports). Coordinate cross-functional activities (R&D, Manufacturing, QA, RA) for seamless transfer and scale-up. Monitor process performance, addressing deviations or challenges. Maintain detailed records of technology transfer activities, ensuring compliance and data integrity. Ensure documentation adheres to cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Manage document archival and retrieval. Process Validation & Scale-Up: Participate in process validation activities for robust manufacturing processes of OSD Formulations. Analyze process data to identify CPPs and CQAs for process control strategies. Troubleshoot technical issues during scale-up and validation, implementing corrective actions. Evaluate the impact of process changes on product quality. Collaborate with engineering and production to optimize manufacturing processes. Ensure compliance with validation lifecycle management. Quality & Regulatory Compliance: Ensure compliance with cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Conduct risk assessments and implement mitigation strategies. Participate in audits, addressing findings and implementing corrective actions. Maintain understanding of regulatory requirements and best practices in OSD Formulation. Oversee CAPA implementation. Promote a culture of quality and compliance. Technical Troubleshooting & Continuous Improvement: Lead troubleshooting during initial commercial batches, identifying root causes and solutions. Apply problem-solving methodologies to address technical challenges in OSD Formulation. Identify process improvement opportunities. Utilize SPC tools to monitor process performance. Implement Lean Six Sigma principles. Champion continuous improvement. Cross-Functional Collaboration & Stakeholder Management: Coordinate with QA, QC, RA, and Production teams. Facilitate communication and collaboration among teams. Manage stakeholder expectations. Build relationships with internal and external partners. Generate progress reports, highlighting milestones, challenges, and risks. Present technical data to teams and management. Lead meetings to discuss project status and make decisions. Act as a liaison between R&D, Manufacturing, and stakeholders. General Expectations and Past Experiences: Possess 8+ years of hands-on experience in technology transfer within OSD manufacturing, demonstrating a strong understanding of the entire process lifecycle. Demonstrate proficiency in preparing and reviewing critical technical documents such as technology transfer protocols, BMR/BPR, and process validation reports. Exhibit a thorough understanding of Quality by Design (QbD) principles and their application in pharmaceutical manufacturing. Showcase strong technical troubleshooting skills with the ability to identify and resolve issues during scale-up and commercial manufacturing. Proven ability to coordinate and collaborate effectively with cross-functional teams, including QA, QC, RA, and Production. Demonstrate a solid understanding of regulatory guidelines (US FDA, EU EMA) and CGMP compliance requirements for pharmaceutical manufacturing. Experience risk assessment methodologies and CAPA management systems in a pharmaceutical setting.

Job Description Summary We are looking for a detail-oriented and compliance-focused QA and Compliance Executive to join our Commercials Department in Mumbai . This role is vital to ensuring that all pharmacovigilance (PV) processes, data documentation, and reporting meet global regulatory standards and internal quality benchmarks. You will play a central role in managing safety data, identifying adverse events, ensuring timely and accurate reporting, and supporting inspection readiness through audits and continuous process improvement. The ideal candidate will have strong knowledge of healthcare regulations such as EMA, FDA, HIPAA, and Good Pharmacovigilance Practices (GVP), along with hands-on experience in PV documentation, quality reviews, and compliance operations within the healthcare or pharmaceutical industry. Key Roles and Responsibilities 1. Pharmacovigilance Reporting & Documentation Ensure accurate and timely collection, documentation, and submission of pharmacovigilance data. Identify, assess, and document Adverse Events (AEs), Serious Suspected (SS) cases, and Special Situation Reports (SSRs). Maintain detailed case records including intake forms, investigation notes, follow-ups, and regulatory submissions. 2. Quality Assurance & Compliance Monitoring Conduct internal quality audits of PV data and processes to ensure alignment with SOPs, GVP guidelines, and international regulatory standards (EMA, FDA). Perform quality checks on safety documentation for completeness, accuracy, and consistency. Identify deviations and implement Corrective and Preventive Actions (CAPA) accordingly. 3. Regulatory Readiness & Reporting Contribute to audit summaries, compliance reports, and documentation needed for regulatory inspections. Support internal and external audit preparation and responses to regulatory queries. Ensure that all case management activities are in compliance with local and global safety reporting obligations. 4. SOP Development & Process Improvement Assist in the creation, review, and refinement of Standard Operating Procedures (SOPs), work instructions, and quality manuals in collaboration with the QA team. Monitor and suggest enhancements to improve quality metrics and operational efficiency. 5. Data Security & Confidentiality Ensure secure handling of all patient and safety data in line with HIPAA, GDPR, and company-specific data protection policies. 6. Cross-Functional Collaboration Liaise with internal teams (Medical Affairs, Operations, Regulatory, and IT) to maintain effective quality and compliance standards. Present audit findings, trends, and improvement opportunities to stakeholders. Qualifications and Skills Required Education: Bachelors degree in Healthcare Administration, Life Sciences, Quality Management, or a related field. Certifications: Certified Quality Auditor (CQA) or similar certification is a plus. Experience: 2–5 years in QA, compliance, or pharmacovigilance within the healthcare/pharma industry. Regulatory Knowledge: Familiarity with GVP, EMA, FDA, HIPAA, and other healthcare compliance frameworks. Skills: Strong analytical and problem-solving skills Excellent attention to detail and documentation accuracy Proficient in compliance and QA software tools Strong verbal and written communication skills Ability to multitask and work independently Why Join Us? Be part of a mission-driven organization committed to healthcare safety and regulatory excellence. Work in a collaborative and growth-oriented environment. Competitive salary and professional development opportunities.