QA Manager Indenta chemicals india pvt ltd

5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, you will be responsible for running the department independently. Your role will require strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Managing and implementing change control processes effectively. - Proficient in preparing and maintaining Site Master Files, Master Validation Plans, and Batch Manufacturing Records (BMRs). - Conducting stability studies, managing stability programs, and handling Out of Trend (OOT) and Out of Specification (OOS) results. - Establishing and maintaining standards according to current regulatory guidelines and Pharmacopeia revisions. - Evaluating deviations, managing change controls, and implementing corrective and preventive actions (CAPA). - Proficient in equipment qualification, process validation, cleaning validation, and method validation. - Overseeing the calibration of equipment and adhering to ICHQ7A guidelines and other regulatory standards. - Conducting trend analysis, providing feedback for continuous improvement, and implementing Quality Risk Management strategies. - Working towards continuous improvement of quality systems and efficiently managing Quality Control departments. - Handling ISO documentation procedures, including quality manuals, work instructions, checklists, and audits. - Managing sampling and testing of excipients, Essential Oils, and Aroma chemicals. - Strong skills in effective manpower handling and communication in English, both oral and written. This is a full-time position with benefits including Provident Fund. The work schedule is day shift, and the work location is in person.,

Posted 3 days ago

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Formulation Researcher I Teva Pharmaceuticals

1.0 - 5.0 years

0 Lacs

maharashtra

On-site

As a bench scientist in our organization, you will be responsible for conducting experimentation and research in the area of formulation development, process development, regulatory affairs, and intellectual property for global markets. Your work will involve planning and executing experiments aligned with project milestones while applying scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be expected to analyze and interpret data from literature reviews effectively to support decision-making processes. Additionally, you will need to understand the intellectual property landscape, develop strategies, search for prior art, and establish proof of concept through experimentation. Collaboration with cross-functional teams including Manufacturing Science and Technology (MS&T), Quality Assurance (QA), Quality Control (QC), and production teams across different geographies will be crucial for technology transfer and timely execution of submission batches. Your role will also involve identifying challenges, bottlenecks in development, and providing mitigation proposals at various stages of product development. Furthermore, you will be responsible for problem-solving, prioritizing activities, conducting development trials, and ensuring alignment with established milestones. Clear communication with internal stakeholders, proactive identification of challenges or risks, and adherence to business unit Key Performance Indicators (KPIs) will be essential aspects of your role. On a day-to-day basis, you will work closely with the formulation development teams to achieve key milestones, conduct experiments following QbD principles, and prepare presentations at different stages of product development. Your tasks will include literature reviews, sourcing API and Excipients, conducting preformulation studies, executing development trials, interpreting analytical data, and preparing necessary documentation for regulatory submissions. To be successful in this role, you should hold a Ph.D. in Pharmaceutical Sciences with at least 1 year of experience or an M.Pharm in Pharmaceutical Sciences with a minimum of 3 years of experience from reputable universities. Prior experience in working with generic pharmaceuticals in regulated markets such as the US, EU, or Canada will be advantageous. Your commitment to personal accountability, effective work habits, continuous learning, and collaboration with internal teams will be instrumental in contributing to the success of our organization's mission to make good health more affordable and accessible globally.,

Posted 6 days ago

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Senior Executive - Quality Assurance Piramal Finance

5.0 - 10.0 years

4 - 6 Lacs

Medak

Work from Office

We are looking for a highly experienced and skilled Senior Executive - Quality Assurance to join our team at PIRAMAL ENTERPRISES LTD. The ideal candidate will have between 5-10 years of experience in QMS, with expertise in handling change control, deviation, OOS, and audit properness. Roles and Responsibility Manage and implement quality management systems to ensure compliance with regulatory requirements. Handle change control, deviation, and OOS issues, ensuring timely resolution and corrective action. Conduct audits to ensure compliance with industry standards and regulations. Develop and maintain electronic systems, including Trackwise and SAP. Collaborate with cross-functional teams to ensure quality assurance and compliance. Analyze data and reports to identify areas for improvement and implement process enhancements. Job Requirements MSc Chemistry or BTech Chemical degree. Possess strong knowledge of QMS principles and practices, including change control, deviation, and OOS management. Experience with electronic systems such as Trackwise and SAP is required. Demonstrate excellent analytical and problem-solving skills, with the ability to interpret data and reports. Exhibit strong communication and collaboration skills, enabling effective teamwork with cross-functional teams. Ability to work in a fast-paced environment, prioritizing tasks and managing multiple projects simultaneously. More than 5 year experience in QMS like handing of change control, deviation, OOS and Audit properness and Audit facing knowledge of electronic system like Track wise, SAP.... Responsibilities Qualifications MSc Chemistry/ BTech Chemical

Posted 1 month ago

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