We are looking for a meticulous Warehouse Executive to optimize warehouse operations at Synnat Pharma Private Limited. As Warehouse Executive, you will play a crucial role in managing the daily operations of our warehouse, ensuring the safe and efficient receipt, storage, and dispensing of raw materials, solvents, and intermediates to production, as well as the dispatch of finished goods. This position requires maintaining strict inventory accuracy, adhering to Good Warehousing Practices (GWP) and Good Distribution Practices (GDP), and ensuring compliance with all relevant pharmaceutical regulatory requirements. The ideal candidate will possess a strong understanding of ERP systems, GRN preparation, and warehouse equipment maintenance. You will also be responsible for monitoring environmental conditions, managing documentation, and participating in warehouse audits. Your role is critical in upholding product quality and safety, supporting our commitment to excellence in the pharmaceutical industry. If you are a detail-oriented professional with a passion for operational efficiency and regulatory compliance, we encourage you to apply and contribute to our continued success. Responsibilities: Oversee daily warehouse operations, ensuring efficient receipt, storage, and dispatch of materials. Manage the flow of raw materials, solvents, and intermediates to production, and finished goods for dispatch. Maintain accurate records of raw materials, solvents, intermediates, and finished goods using ERP systems. Conduct regular inventory audits to ensure accuracy and identify discrepancies, implementing corrective actions. Maintain product quality and safety through effective warehousing and distribution practices (GWP and GDP), adhering to Synnat Pharma's quality standards. Ensure compliance with pharmaceutical regulatory requirements (GMP) and internal quality standards, actively participating in audits (USFDA, MHRA) and leading preparations as required. Manage the storage of materials under required temperature and humidity conditions, monitoring and addressing any excursions promptly. Ensure safe handling and storage of solvents, adhering to all safety protocols and regulations, including proper labeling and identification of all materials. Coordinate with procurement and production teams to ensure timely availability of materials, managing material expiration dates and obsolete stock disposal in compliance with environmental regulations. Manage the Goods Received Note (GRN) process from preparation to QC intimation of incoming materials, ensuring compliance with traceability requirements. Prepare and submit regular reports on warehouse operations, inventory levels, and compliance activities, maintaining all records in accordance with regulatory requirements and company policies. Ensure proper operation and maintenance of warehouse equipment, such as forklifts and pallet jacks, and oversee the calibration and performance verification of weighing balances and other measuring equipment. General Expectations and Past Experiences: Bachelor's degree with 4-7 years of experience in warehouse operations/regulatory audit within the pharmaceutical industry, preferably in API. Experience and Knowledge of Regulatory Audit and Customary Audit parameters is preferred. Proven expertise in Warehouse Operations Management, Materials Management, and Inventory Control using ERP Systems (SAP, Oracle). In-depth knowledge of Good Warehousing Practices (GWP), Good Distribution Practices (GDP), and Pharmaceutical Regulatory Requirements (GMP). Hands-on experience in Finished Goods Handling, Raw Materials Management, Intermediates Management, and Solvent Handling. Ability to prepare and manage Goods Received Note (GRN) from preparation to QC intimation, ensuring accuracy and compliance. Excellent communication skills in English, Hindi, and Telugu, with the ability to work independently and collaboratively. Willingness to work flexible hours and participate in warehouse audits, demonstrating a commitment to maintaining high standards.
We are looking for a meticulous Senior Executive or Assistant Manager to lead regulatory filings at Synnat Pharma Pvt Ltd, a rapidly expanding company in the Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will be instrumental in navigating the complex landscape of pharmaceutical regulations, ensuring our API products meet the stringent requirements of global regulatory bodies, particularly the US FDA. Your expertise will be crucial in preparing and submitting Drug Master Files (DMFs) and eCTD-compliant documentation, managing regulatory inspections, and proactively mitigating regulatory risks. You will collaborate closely with API manufacturing, quality control, and research teams to develop and implement robust regulatory strategies. Responsibilities will also include conducting regulatory audits, ensuring adherence to ICH guidelines, and managing the lifecycle of API products from a regulatory perspective. A deep understanding of pharmaceutical regulations, coupled with the ability to interact with regulatory authorities, will be essential for ensuring compliance and expanding into regulated markets. Job Details: Industry: Active Pharmaceutical Ingredients (API) Department: Regulatory Affairs Role: Senior Executive / Assistant Manager Regulatory Affairs Location: Visakhapatnam Compensation: 5 to 10 LPA Experience: 7 to12 years Employment Type: Full-time Qualification: Bachelors or Master’s degree in Pharmacy, Chemistry, or a related field Responsibilities: Prepare, review, and submit comprehensive regulatory filings including DMFs, variations, and renewals, ensuring compliance with global regulations. Manage the eCTD compilation and submission process for API products, ensuring accuracy and adherence to timelines. Lead documentation preparation for regulatory inspections, responding to queries from authorities. Conduct regulatory audits of API manufacturing processes to ensure compliance with cGMP requirements. Develop and implement CAPA plans to address regulatory gaps or deficiencies. Monitor and track the status of filings, proactively addressing issues to secure timely approvals. Develop regulatory strategies for API products, considering market access requirements and regulatory trends. Identify and mitigate regulatory risks, ensuring compliance with ICH and US FDA guidelines. Provide regulatory guidance and support to cross-functional teams and ensure change control compliance. Manage the regulatory aspects of API product lifecycle from development through commercialization and post-market surveillance. Collaborate with manufacturing, QC, and R&D teams to ensure compliance throughout the product lifecycle. Participate in product recalls, adverse event reporting, and lifecycle management activities. General Expectations and Experience: 7–12 years of proven experience in API Regulatory Affairs Strong knowledge of US FDA regulations, ICH guidelines, and cGMP compliance. Hands-on expertise in DMF preparation, eCTD submissions, and regulatory audits/inspections. Experience in API manufacturing processes and documentation requirements. Excellent communication, documentation, and negotiation skills with regulatory authorities. Proficiency in Regulatory Compliance Management and change control processes.