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Teva Pharmaceuticals
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Principal Scientific Publisher

Principal Scientific Publisher

Teva Pharmaceuticals

12 - 16 years

0 Lacs

maharashtra

Posted:1 week ago| Platform: Shine logo

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Skills Required

formulation sops qbd doe statistical analysis regulatory documentation technical writing microsoft applications statistical tools data mapping grammar punctuation problem solving pharmaceutical research development fda regulations ich guidelines usp methodologies cgmps shelflife extrapolation good manufacturing practices gmp english spelling

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for preparing consistent and high-quality technical documents related to Pharmaceutical Research and Development for Formulation at Teva. Your role will involve executing all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs, and SOPs. Maintaining open communication with R&D members to ensure timely delivery of high-quality documents independently with minimal supervision will be a key aspect of your responsibilities. Key Responsibilities: - Prepare documents and facilitate documentation management in R&D while ensuring correctness, completeness, and clarity following established guidelines. - Prepare documents such as Manufacturing Batch Records, Study Protocol and Reports, Stability Protocols, Product Development Report, Quality Overall Summary, response to regulatory queries based on scientific input from the Formulation team. Knowledge of QBD & DOE is essential. - Prepare high-impact presentations including graphs and charts. - Submit documents for signatures, coordinate their flow, archival, and retrieval to ensure timely flow and publish monthly performance metrics. - Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements. - Perform other duties as assigned or delegated. - Comply with FDA guidelines/Company Policies of Data Integrity. Qualifications Required: - Education: A minimum of a master's degree (M.Pharm) or a PhD in Pharmacy is required. - Industry Experience: Minimum 12 to 15 years of Formulation R&D experience with solid oral dosage forms for regulated markets. Knowledge of other dosage forms will be an added advantage. - Demonstrated knowledge and understanding of quality and regulatory guidance for SOD products for regulated markets. - Demonstrated knowledge and working understanding of basic concepts of Good Manufacturing Practices (GMP), regulatory documentation required. Additional Company Details: Together, Teva is on a mission to make good health more affordable and accessible worldwide. As the world's leading manufacturer of generic medicines, Teva is dedicated to helping millions enjoy healthier lives. With a presence in nearly 60 countries and a diverse workforce, Teva is always looking for new ways to make a difference and welcomes individuals who share the same mission. Note: The job description did not include any additional details about the company.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Principal Scientific Publisher

Teva Pharmaceuticals

maharashtra

Principal Scientific Publisher

Teva Pharmaceuticals

maharashtra

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Principal Scientific Publisher