5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As an Assistant Manager/Manager- Quality Assurance, your responsibilities will include: - Reviewing and approving Standard Operation Procedures (SOP's) for all departments, ensuring timely completion of reviews and revisions according to the specified revision date. - Evaluating and approving analytical method validation protocols and reports, process method validation protocols and reports, water system validation protocols and reports, as well as equipment/instrument qualification protocols and reports. - Reviewing and approving raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Approving artwork and shade cards for printed packing material. - Overseeing and approving stability protocols and data. - Coordinating and supporting on-site audits conducted by customers and agencies, and implementing necessary corrective actions based on audit findings. - Developing, preparing, and implementing quality systems across the site. - Providing training to all staff members. - Reviewing and approving deviations, change control, and CAPA processes. - Planning and conducting internal audits for all departments. - Reviewing and approving batch manufacturing and batch packing records. - Ensuring the quality of manufactured products through an in-process quality assurance system. - Reviewing executed batch manufacturing records, batch packing records, finished product test reports with analytical data, and subsequently releasing batches for market distribution. - Ensuring data integrity compliance at the site. - Maintaining and improving product quality by conducting product, company, system, compliance, and surveillance audits, and investigating customer/market complaints. - Preparing FDA licensing documents, QA documents for export orders. - Creating quality documentation and reports by collecting, analyzing, and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions, and re-validations. - Undertaking any additional responsibilities assigned by higher management as needed.,

Posted 2 weeks ago

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Director, Technical Operations Azurity Pharmaceuticals

15.0 - 19.0 years

0 Lacs

hyderabad, telangana

On-site

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products to serve underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline by leveraging integrated capabilities and a vast partner network. The company's patient-centric offerings span various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a team of talented individuals committed to enhancing patient lives through a combination of cutting-edge science and unwavering dedication to quality. The company values highly motivated individuals with integrity, dedication, and creativity to thrive within its organization. The Technical Operations department at Azurity is responsible for overseeing technical process strategy, managing contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), and delivering product objectives in line with company policies and client requirements. This role involves leading teams, collaborating cross-functionally, and achieving project milestones to support process scale-ups, validation, technical transfers, post-approval changes, and investigations for commercial products. **Principal Responsibilities:** - Manage the planning and execution of manufacturing activities, including qualification and validation for both development and commercial products. - Coordinate with contract facilities to review, approve, and execute controlled documentation related to late-stage development, qualification, validation, and manufacturing activities. - Direct tasks associated with late-stage product/process development, product transfers, equipment qualifications, and validation to ensure alignment with company objectives. - Support or lead product launch and commercialization efforts. - Establish and maintain policies, SOPs, and documentation to support validation practices per regulatory requirements and industry guidance. - Assist in Management Review and Compliance activities, preparing metrics and summaries for senior management communication. - Support Due Diligence activities related to product development, technical transfer, manufacturing, and commercial launch. - Collaborate with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. **Qualifications And Education Requirements:** - Bachelor's degree in Life Sciences (Master's degree preferred) or related field. - Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry. - Expertise in cGMPs, ICH, and Validation related requirements. - Proficiency in technical transfer of multiple dosage forms, various validation disciplines, and regulatory agency inspections. - Ability to work strategically, tactically, and hands-on. - Proficient in Microsoft Word, Excel, and Powerpoint. By applying for this role, you confirm your capability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,

Posted 1 month ago

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