12 Quality Agreements Jobs

As a Vendor Quality Assurance Specialist, your role is crucial in ensuring that all vendors supplying materials meet the company's quality standards and regulatory requirements through a structured vendor qualification and evaluation process. Key Responsibilities: - Initiate and coordinate vendor qualification activities for both new and existing vendors. - Prepare and maintain vendor qualification dossiers and files to ensure documentation accuracy. - Coordinate with procurement and other departments to gather necessary vendor data and documentation efficiently. - Ensure vendors comply with Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards to uphold ...

In this role at Piramal Agastya, your primary responsibility is to ensure compliance with regulatory and Pharmacopoeial standards through compendia assessments, Quality Management System (QMS) oversight, and documentation preparation. You will collaborate with global sites, vendors, and internal teams to develop quality agreements and provide support during audits and inspections. Additionally, you will be managing SOPs, monitoring QMS events, and preparing essential quality documentation and reports. As part of your responsibilities, you will: - Conduct compendia assessments for all materials used on-site to identify gaps against current Pharmacopoeial requirements and implement risk mitiga...

Role Overview: 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. Key Responsibilities: - Review and approve all documents including SOPs, Spec & STPs, Forms, protocols, and reports to ensure compliance. - Review annual product quality review reports and provide training on cGMP topics to employees at the site. - Support customer audits/visits and regulatory a...

As a Qualified Person within the Quality department at Piramal Critical Care (PCC) in Haarlem, Netherlands, your primary responsibility will be to certify batches of Medicinal Products before release for sale. This includes ensuring compliance with EU-GMP regulations, relevant EU-directives such as 2001/83/EC and 2011/62/EU, Dutch National Legislations, and overseeing that public service obligations are met. - Collaborate with key personnel like heads of production, quality control, quality assurance, and supply chain to supervise the company's activities and ensure continuous compliance with legal requirements. - Be regularly present at the facilities where the operations take place to fulf...

Oversee QA For Contract Manufacturing: Draft Agreements, Review Batch Docs, CoAs, Deviations, And Artwork. Ensure GMP Compliance, Traceability, And Regulatory Alignment. Support IPQA Checks, Sampling, Audits, And Real-Time Issue Resolution. Required Candidate profile Skilled in corporate QA documentation, third-party coordination, and artwork review Manage change control, audit readiness, and traceability Ensure regulatory compliance and product release approval

As a Packaging Material Procurement Specialist at Zydus, you will play a crucial role in ensuring compliance with regulatory requirements for vendor development, particularly focusing on vendors from European, US, and other regulatory countries. Your responsibilities will include maintaining effective communication with imported vendors, arranging samples and vendor documents, conducting vendor audits, and managing quality agreements. You will be expected to coordinate with various cross-functional teams such as PTC, CQA, IRA, and others for developmental activities. Keeping the team updated on material availability status through COE and regular meetings will be essential. Additionally, ens...

As the Purchasing Manager at our company, you will be responsible for leading the day-to-day purchasing operations of various categories including raw materials, solvents, intermediates, packaging materials, engineering spares, and capex items. Your role will involve developing, qualifying, and managing a global supplier base, while negotiating contracts for cost, quality, and compliance. It is essential to maintain strong vendor relationships, monitor inventory levels, and coordinate capex projects, site expansions, and new machinery purchases to ensure uninterrupted production support. In this role, you will be expected to ensure that all materials suppliers meet the cGMP and ICH Q7 standa...

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...

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, corp...

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 docume...

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 a...

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 ...