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4 Audit Preparedness Jobs

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8.0 - 12.0 years

0 Lacs

andhra pradesh

On-site

As an experienced professional in the field of Quality Management Systems (QMS), you will be responsible for various key activities including handling of Corrective and Preventive Actions (CCF), Deviations, Out of Specification (OOS) incidents, and more. Your role will involve the preparation and thorough review of Standard Operating Procedures (SOPs), Equipment Operating Procedures (EOPs), Operational Control Plans (OCPs), Batch Manufacturing Records (BMR), and other crucial production documents. In addition, you will play a significant part in reviewing batch reports, identifying opportunities for productivity enhancements, and conducting investigations into batch failures. Your expertise will be instrumental in the development of critical documents such as the Accident and Incident Management (AIM) register and Hazard Identification and Risk Assessment (HIRA) register. Furthermore, you will be involved in conducting Hazard and Operability (HAZOP) studies to ensure a comprehensive approach to risk management. Collaboration will be a key aspect of your role as you will work closely with the Quality Assurance (QA) team to facilitate validation, qualification, and audit readiness activities. Adherence to established Standard Operating Procedures (SOPs), product specifications, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) will be paramount to ensure compliance and quality standards are consistently met. Your responsibilities will also encompass the meticulous review of all completed documents to verify their accuracy, completeness, and proper authorization. Real-time data entry into Quality records and proficiency in handling electronic Batch Manufacturing Records (e-BMR) through systems like SAP will be essential to maintain efficient operations. A solid understanding of Automation systems such as Distributed Control Systems (DCS), Manufacturing Execution Systems (MES), and Energy Management Systems (EMS) will further enhance your ability to streamline processes and drive operational excellence. If you possess a BSc or MSc qualification along with a proven track record of 8 to 10 years in a similar role, and if you are looking to make a significant impact in a dynamic work environment, we invite you to consider this opportunity to contribute your expertise and drive continuous improvement in our organization.,

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3.0 - 7.0 years

0 Lacs

andhra pradesh

On-site

As a candidate for this role, you will be responsible for handling various Quality Management System (QMS) activities such as managing Corrective and Preventive Actions (CCF), deviations, and Out of Specification (OOS) incidents. Your duties will include preparing and reviewing Standard Operating Procedures (SOPs), Equipment Operating Procedures (EOPs), Operating Control Plans (OCPs), Batch Manufacturing Records (BMR), and other production-related documents. Additionally, you will be required to review batch reports, participate in productivity improvement initiatives, and investigate batch failures. You will also be responsible for creating and maintaining the Asset Integrity Management (AIM) and Hazard Identification and Risk Assessment (HIRA) register, as well as conducting Hazard and Operability (HAZOP) studies. In this role, you will collaborate closely with the Quality Assurance (QA) team to ensure validation, qualification, and audit readiness. It is essential to strictly adhere to Standard Operating Procedures, product specifications, Good Manufacturing Practices, and Good Documentation Practices. You will be responsible for reviewing all completed documents to ensure completeness and proper sign-off, as well as accurate data entry in Quality records. The ideal candidate for this position should have a Bachelor's (BSc) or Master's (MSc) degree and possess 3 to 4 years of relevant experience in a similar role.,

Posted 1 week ago

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7.0 - 11.0 years

0 Lacs

gujarat

On-site

As a Store Manager at our pharmaceutical manufacturing unit in Nadiad, you will be responsible for overseeing and managing the inventory and warehousing operations. With 7-10 years of experience in pharmaceutical warehousing, you will utilize your expertise in GMP and GDP to maintain compliance with regulatory guidelines. Your role will involve managing day-to-day store operations, ensuring proper storage conditions, and monitoring inventory levels to prevent stock-outs or overstocking. You will lead a team of store assistants, operators, and forklift drivers, while collaborating with various departments to ensure seamless operations. Your responsibilities will include overseeing material handling, maintaining accurate documentation, and preparing for internal and external audits. Proficiency in ERP systems such as SAP or Oracle will be essential for managing inventory and generating reports for management. To qualify for this role, you should hold a Bachelor's degree in Pharmacy, Science, or a related field, with a diploma in Materials Management or Supply Chain being an added advantage. Strong knowledge of pharmaceutical regulations, GMP, GDP, and experience in handling APIs, excipients, and hazardous materials are required. Key skills such as leadership, analytical thinking, communication, and audit preparedness will be crucial for success in this position. Preferred certifications in GDP/GMP training, ISO standards, and relevant ERP systems will further enhance your candidacy for this role. Join us in ensuring efficient warehouse management and maintaining high standards of quality and compliance in our pharmaceutical manufacturing facility.,

Posted 1 month ago

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10.0 - 14.0 years

0 Lacs

punjab

On-site

As an experienced and versatile Manager, Operations & Administration at Expansion Desk in Kurali (Punjab), you will be responsible for overseeing the critical support functions of the company. With a minimum of 10 years of experience in an organized sector, you will demonstrate a comprehensive understanding of best practices in human resources, manpower management, accounts, and various company certifications and compliances. Reporting to the directors, you will play a crucial role in ensuring smooth and efficient operations to support manufacturing practices, the team, and regulatory adherence. Your key responsibilities will include: Human Resources (HR): - Talent Management: Oversee employee performance, create incentivization systems, maintain discipline, and make day-to-day decisions for factory operations. - Policy & Compliance: Implement and enforce HR policies in line with labor laws and company regulations, ensuring overall compliance. - Employee Engagement: Foster a positive work environment through effective communication, conflict resolution, and initiatives promoting employee well-being. Accounts & Finance Support: - Budgeting Support: Assist in budget preparation, monitoring, and financial reporting to aid in business decision-making. - Compliance: Ensure adherence to tax regulations (e.g., TDS, GST) and other financial compliances. Certifications & Compliance: - Regulatory Adherence: Identify and track necessary company licenses, permits, and certifications for timely renewals (e.g., ISO, industry-specific, local business licenses). - Audit Preparedness: Prepare the company for internal and external audits, ensuring documentation and processes are in order. - Risk Management: Proactively identify and mitigate operational risks related to compliance and administration. General Administration & Operations: - Office Management: Oversee office administration, including supply procurement, facility maintenance, and vendor management. - Process Improvement: Identify opportunities for process optimization and implement efficiencies across administrative and operational functions. - Cross-Functional Collaboration: Work with departments to understand their administrative and operational needs, providing effective support. - Record Keeping: Maintain accurate and organized company records, both physical and digital. Qualifications: - Bachelor's degree in electrical, electronics, or mechatronics engineering. - Previous experience as a General Manager in the same domain is preferred. - Minimum of 10 years of progressive experience in a managerial or senior administrative role within an organized sector company. - Demonstrated knowledge and hands-on experience in HR, Accounts, and managing company certifications/compliances. - Understanding of Indian labor laws, tax regulations (e.g., Income Tax, GST), and general business compliances. - Proficiency in basic accounting. - Excellent communication, interpersonal, and leadership skills. - Strong organizational and time management abilities with attention to detail. - Ability to work independently, prioritize tasks, and manage multiple responsibilities effectively. - Problem-solving attitude and proactive approach to challenges.,

Posted 1 month ago

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