5 Quality Agreements Jobs

As an Assistant Manager EQA, you will be responsible for overseeing the vendor qualification program and ensuring compliance with regulatory standards. Your primary duties will include conducting vendor qualification and requalification activities to maintain ongoing compliance. This will involve conducting license and documentation checks to uphold the Global Supplier Bona Fide program and Distributor Chain of Custody programs. You will be tasked with preparing and executing new and existing Quality Agreements as part of the periodic review program. Your role will also involve managing the Global GMP Vendor Master/Qualification Data in SAP, including monitoring expiration dates and ensuring timely escalation and remediation of supplier compliance risks and failures within your scope. You will collaborate closely with cross-functional stakeholders for remediation purposes and work in alignment with direct line management. To excel in this role, you must demonstrate Endo Values and uphold the Endo Code of Conduct through your actions. You will engage with functional employees to ensure their compliance with GMP, Values, and Code of Conduct training. Additionally, you will actively participate in Good Catch and Continuous Improvement programs to drive excellence within the organization. The ideal candidate for this position should hold a Master's degree in Chemistry, with hands-on experience in the API industry. You should have a strong background in API Synthetic Chemistry review, as well as experience in Quality and Manufacturing processes. A minimum of 10 to 14 years of relevant experience is required to be considered for this role. Commitment to Diversity, Equity, and Inclusion is a core value that we uphold at our organization, and we expect all employees to champion these principles in their daily practices.,

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary documents for amendments, annual updates, regulatory filings, and CMC supporting documentation. Other tasks may include filling out questionnaires, declarations, quality agreements, and executing any additional responsibilities assigned by the Head of Department.,

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

You will be responsible for ensuring compliance and further development, support, maintenance, and constant review of the Quality Systems, as well as supporting projects and reporting necessary performance indicators (KPIs) and quality indicators (KQIs). Your role will involve supporting the implementation of effective and efficient processes that meet regulatory requirements and expectations for the global Novartis product portfolio. As the Global QMS Manager based in Hyderabad Hybrid, you will be accountable for developing, implementing, and continuously improving processes within the Third-Party Management Global Quality System. This includes ensuring compliance with cGMP/ICH, Regulatory Authority, and Novartis Group Quality Manual requirements and policies. You will need to stay updated with industry trends and Health Authority expectations to incorporate them into Novartis QMS. Your key responsibilities will include being the Process Owner for Supplier Lifecycle Management and Quality Agreements, supporting the execution of the Quality System strategy, driving simplification and optimization of processes, reviewing and updating process-related documentation, assessing technology needs, ensuring compliance with regulations, participating in benchmarking activities, authoring QMS documentation, acting as a subject matter expert for relevant IT systems, interacting with stakeholders, and supporting quality-related initiatives. To be successful in this role, you must have fluent spoken and written English, thorough knowledge of cGMP requirements, at least 10 years of experience in pharmaceutical industrial Quality and Compliance activities, strong analytical and risk management skills, good interpersonal and communication skills, experience in a matrix organization, and familiarity with supplier management and quality agreement processes. Novartis aims to improve and extend people's lives by reimagining medicine and becoming the most valued and trusted medicines company globally. Joining Novartis means being part of a mission-driven organization where associates are empowered to reach ambitious goals. If you are looking to contribute to a brighter future in healthcare, consider joining our network to stay connected and explore career opportunities with Novartis.,