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10.0 - 14.0 years
0 Lacs
vadodara, gujarat
On-site
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.,
Posted 2 days ago
8.0 - 12.0 years
0 Lacs
chennai, tamil nadu
On-site
You will be responsible for supporting the objectives of the Health, Safety, Security, Environmental, Sustainability, and Quality Policies as well as the Information Security Management Policy by adhering to applicable Procedures and Work Practices while fulfilling your duties. Your role will involve carrying out various piping activities, preparing deliverables as identified in Functional Competencies, and signing drawing/documents as an originator in accordance with correct procedures. Ensuring quality in design, technical accuracy in the preparation of drawings, material quantities, etc., will be a key part of your responsibilities. You will execute assigned work in accordance with applicable contract procedures, client, and project standards. Adhering to engineering procedures for design safety and adopting safe attitudes towards engineering design, as well as raising features affecting the safety and integrity of the project with appropriate authorities, will also be expected. You will be responsible for the correct implementation of all piping CAD and system-related functions for your appointed area. To be successful in this role, you should have a minimum of 8 years of experience in the detail engineering of process plants. Project/site experience working in a variety of projects including grassroots, brownfield, and revamp types is essential. You should possess sound knowledge of all general piping design, developing experience in piping layout, and phases of plot plan development. Some experience in site-based design in support of construction is preferred. Being experienced and proficient in executing work using intelligent CAD systems will be advantageous. Wood is a global leader in consulting and engineering, helping to unlock solutions to critical challenges in energy and materials markets. They provide consulting, projects, and operations solutions in 60 countries, employing around 35,000 people. Learn more about Wood at www.woodplc.com.,
Posted 2 weeks ago
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