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1.0 - 5.0 years
0 Lacs
gujarat
On-site
As a QC Chemist at INFINIUM PHARMACHEM LIMITED, an NSE Listed pharmaceutical intermediates & APIs manufacturing company established in 2003, you will play a vital role in ensuring the quality and compliance of our products. We are seeking an enthusiastic individual with a strong background in M.Sc. and 1 to 3 years of experience to join our team. Your responsibilities will include assisting in QC stability testing, preparing and maintaining stability records, modifying and validating analytical procedures, supporting the design and development of experimental protocols consistent with cGMP/GLP, and executing special projects on analytical and instrument problem solving. You will also be responsible for conducting all quality QC chemical tests, adapting, maintaining, and operating analytical instrumentation, reviewing procedures, proposing modifications and updates, and ensuring a clean and safe work environment in compliance with safety and pharmaceutical regulations. Additionally, you will be expected to conduct radiation safety duties conforming to regulations, contribute to industrial, R&D qualification, and validation activities, support routine maintenance, and perform various analytical testing procedures as per manufacturing/QC SOPs. The job location for this position is at our factory in Sojitra, Dist. Anand, Gujarat, on a full-time basis with a fixed shift schedule. If you are passionate about quality control in the pharmaceutical industry and possess the necessary skills and qualifications, we encourage you to apply for this exciting opportunity to be part of our dynamic team at INFINIUM PHARMACHEM LIMITED.,
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
vadodara, gujarat
On-site
As a Senior Auditor at our organization, you will play a crucial role in leading audit engagements and ensuring the delivery of high-quality audit outcomes that align with both international and local standards. Your responsibilities will include developing audit plans, executing fieldwork, preparing audit reports, and ensuring compliance with regulatory requirements. Additionally, you will have the opportunity to mentor junior staff, contribute to process improvement discussions, and recommend enhancements to audit processes. In terms of qualifications, we are looking for candidates who are ACCA/ACA qualified or near qualification, possess a Bachelor's degree in Accounting, Finance, or a related field, and have at least 3-4 years of audit experience. Fluency in both Greek and English, both written and spoken, is essential for effective communication with clients and team members. Key skills that will contribute to your success in this role include strong communication and teamwork abilities, the capacity to manage multiple priorities, a keen attention to detail, and a proactive and solutions-oriented mindset. It is imperative that you stay updated with IFRS, ISAs, local tax laws, and company regulations to ensure that audits meet the required professional and regulatory standards. If you are a motivated and experienced individual who thrives in a dynamic audit environment and is committed to delivering exceptional audit services, we invite you to apply for this position and be a part of our dedicated audit team.,
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
The main responsibilities of this role include performing various tasks such as Risk Assessments, Process Walkthroughs, documenting Process Narratives and Flow Diagrams, finalizing Risk and Control Matrix, conducting Test of Control Effectiveness, supporting remediation efforts for control failures in compliance with SOX and ISAE SSAE. This role also involves performing Interventions and Special Assignments at Client Engagements to identify reasons for operational failures, critical errors, and process weaknesses. Additionally, the responsibilities include conducting Root Cause Analysis, remediating and resolving causes, and reporting to internal and external stakeholders on risk trackers and remediation status. The ideal candidate should possess reasonable knowledge of processes like AP, AR, and RTR, along with reasonable knowledge of F&A Audit Processes including Internal Operational and Financial Audits. Knowledge of key F&A compliances such as ISAE 3402, SSAE 16, and SOX is required. Strong analytical skills, spreadsheet skills, and an excellent command over the English language are essential for this role. Experience of working in a GBS delivery environment and executing Analytical Procedures using currently available tools is preferred. Desirable knowledge of ERP or Information System Design and Operation (e.g., SAP, Oracle Financials) and reasonable knowledge of Information Technology (ITGC Controls, Information Systems Audit) are also beneficial. The educational qualifications required for this role include being a Chartered Accountant with 3-4 years of post-qualification audit experience. A desirable qualification of CISA and supervisory review experience of at least 1 year are preferred. Preferred Skills for this role include Finance & Accounts expertise.,
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
jharkhand
On-site
The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Procedures, Validation Protocols and Reports, Certificates of Analysis, stability protocols, and reports. You will also be responsible for reviewing vendor documents related to API, Excipients, and Packing materials to ensure adequacy and compliance. Furthermore, you will be involved in the preparation, review, and compilation of ANDAs, Amendments, and Supplements in eCTD format. Collaboration with the Regulatory Operation team member for uploading submissions in eCTD software and reviewing exported submissions for submission will be part of your routine tasks. It is also essential to monitor the FDA website for any updates. To qualify for this role, you should possess a Master of Pharmacy in the Department of Pharmaceutics and have at least 3-5 years of experience in Regulatory Affairs.,
Posted 1 month ago
13.0 - 17.0 years
0 Lacs
surat, gujarat
On-site
You will be joining the Audit team at Auzin Advisory Private Limited as an Assistant Auditor. Your primary responsibility will be to assist in the planning, execution, and finalization of external audit engagements. This involves performing substantive testing and analytical procedures on financial statements in accordance with Australian Auditing Standards (ASA). Additionally, you will review and verify financial records, reports, and internal control processes. It is essential to prepare workpapers and audit documentation in compliance with firm and professional standards. You will also be in regular communication with onshore audit managers and partners to clarify requirements and timelines. Identifying audit issues and effectively communicating findings with recommendations will be a crucial part of your role. Proficiency in audit software such as CaseWare, MYOB, Xero, or APS is required. Keeping up to date with Australian financial reporting and auditing regulations is essential. To qualify for this role, you should have a Bachelor's degree in Accounting, Finance, or a related field. Being part-qualified or qualified CA/CMA/CPA/ACCA is preferred. You should have at least 3 years of audit experience, preferably in a public accounting or outsourcing environment. Proficiency in Microsoft Office and audit software is necessary. Strong numerical and analytical skills with excellent attention to detail are key requirements. Effective communication skills and the ability to work collaboratively within a team are essential. Managing multiple tasks and deadlines efficiently is expected. A commitment to ongoing professional development and training is highly valued. You should be able to meet deadlines and work well under pressure. Demonstrating initiative, influence, and problem-solving skills is important. Being friendly and able to communicate effectively with individuals at all levels is necessary. High sensitivity and awareness of working with people from diverse cultural backgrounds are crucial. Excellent problem-solving, critical thinking, deductive reasoning, inductive reasoning, and analytical skills are required. Strong project management skills, especially in organization, prioritization, and time management, are essential. Managing ambiguity, risk, and adjusting project directions are part of the role. Willingness to work onsite in the Surat office is a must. In terms of behavior, you should be proactive, independent, and have a can-do attitude. Good communication skills and being a team player are important attributes. Benefits: - Food provided - Health insurance - Personal Accidental Insurance - Leave encashment - Paid sick time - Paid time off - Provident Fund,
Posted 2 months ago
3.0 - 6.0 years
3 - 6 Lacs
Bengaluru / Bangalore, Karnataka, India
On-site
Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications M. Pharm (Pharmaceutical Analysis) / M. Sc Chemistry Additional Information Experience level : 0 - 2 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience
Posted 3 months ago
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