As a General Manager of Quality Assurance with 5-10 years of experience, your responsibilities will include validations and qualifications, preparation and implementation of the VMP & CMP, process validations, cleaning validation, and facility validation. You will also be in charge of equipment and instrument qualifications including URS, DQ, IQ, OQ, and PQ. Handling of deviations/incidences, internal quality audits, GMP audit system, annual product review, vendor audits, and qualifications are crucial aspects of this role. Your duties will also involve documentation, effective implementation of the document control system, preparation of Standard Operating Procedures (SOP), GMP & GLP records, and approval of Master Formula Records and batch manufacturing records. Quality control and stability studies will be under your supervision, and you should be fully conversant with the latest GLP requirements. Experience in handling sophisticated instruments like HPLC, GC, FTIR independently is required. Moreover, familiarity with ANDA and EU submissions, handling of regulatory deficiencies/queries work, preparation of Drug Master Files & dossiers for export markets are important responsibilities. Your expertise in ensuring compliance with quality standards and regulations will be essential in this role. If you are a detail-oriented professional with a solid background in quality assurance and a proven track record of successfully managing quality control processes and regulatory submissions, we encourage you to apply for this position.,
As an Officer Quality Assurance with 1-3 years of experience at Sky Biotech, your responsibilities will include conducting QA activities, handling documentation, implementing SOPs, managing IPQC activities, ensuring process control, and coordinating with other departments such as Production, Store, Quality Control, and Engineering. You will be actively involved in establishing quality systems to maintain high standards across the organization. This role requires meticulous attention to detail, strong communication skills, and the ability to work collaboratively with cross-functional teams to ensure compliance and quality assurance throughout the organization.,
As a Plant Manager (Assistant) with 5 to 10 years of experience, your main responsibility will be the approval of sections related to Tablets, Capsules, and Powder within the company. Your role will involve working closely with the Human Resource Department under the supervision of Mr. Prasad Kulkarni, the HR Manager. To excel in this position, you should have a solid understanding of plant management practices and regulations, as well as substantial experience in the pharmaceutical industry. Your decision-making skills and attention to detail will be crucial in ensuring the quality and efficiency of the production process. If you are a proactive individual with excellent communication skills and the ability to work well in a team, we encourage you to apply for this challenging yet rewarding role. Join our dynamic team at SkyBiotech and contribute to the success of our organization.,
As a Quality Assurance Executive at Sky Biotech, you will be responsible for ensuring the highest standards of quality in documentation, SOPs, IPQC activities, and process control. With 3 to 8 years of experience in this field, you will play a key role in inter-department coordination and establishing a robust quality system. Your primary duties will include meticulously maintaining documentation, implementing standard operating procedures, conducting in-process quality control activities, and overseeing the overall quality assurance processes. You will work closely with various departments to ensure seamless coordination and collaboration in maintaining quality standards. The ideal candidate for this role should have a strong background in quality assurance practices, excellent attention to detail, and the ability to effectively communicate and collaborate with different teams. If you are passionate about maintaining high-quality standards and driving continuous improvement in quality systems, we welcome you to join our dynamic team at Sky Biotech.,
As a Trainee Executive in the Packing Section with a requirement of 2 years of experience, your main responsibility will be to manage and schedule the packing plan for various products across different sections. This includes efficiently allotting manpower for packing tasks and ensuring that the packing is carried out effectively. You will be expected to report all activities to the senior management and prepare documents such as Batch Manufacturing Records (BMR) and Batch Packing Records (BPR). It is essential to achieve the targets set for the Packaging Section and have a comprehensive understanding of Current Good Manufacturing Practice (CGMP). Furthermore, you should be familiar with facing Good Manufacturing Practice (GMP) audits.,
As an Assistant Manager - Quality Control in the Production department at Sky Biotech, your role will involve providing quick and on-time results to the IPQC department. Your responsibilities will include handling all documentation work related to RM, IPQC, FP, stability samples, validation, etc. Additionally, you will be in charge of executing and reviewing instrument qualification (IQ, OQ, & PQ). **Key Responsibilities:** - Provide timely and accurate results to the IPQC department - Manage documentation tasks for various processes including RM, IPQC, FP, stability samples, and validation - Execute and review instrument qualification procedures (IQ, OQ, & PQ) **Qualifications Required:** - Bachelor's degree in a relevant field - Minimum of 12 years of experience in Quality Control within a production environment If you need any further information about the company or the role, please do not hesitate to ask.,
**Job Description:** As an Executive in the Packaging Material (PM) Procurement team at Sky Biotech, your role involves developing a procurement strategy to support the achievement of business objectives related to Packaging Material. You will drive sourcing process excellence by ensuring high efficiency in transactions, reducing procurement lead times, implementing strategic sourcing practices, and managing material efficiently. Your responsibilities will include executing strategic sourcing initiatives aligned with the organization's objectives and taking charge of vendor management. This involves building and maintaining vendor relationships, resolving issues that may arise, and identifying and developing new vendor partnerships. **Key Responsibilities:** - Develop a procurement strategy for Packaging Material to support business objectives - Drive sourcing process excellence, focusing on high transaction efficiency and reduced lead times - Implement strategic sourcing initiatives in alignment with organizational goals - Manage vendor relationships, resolve issues, and identify opportunities for new vendor partnerships **Qualifications Required:** - Bachelor's degree in a relevant field such as Supply Chain Management, Business Administration, or a related discipline - Proven experience in procurement, sourcing, or vendor management roles - Strong communication and negotiation skills - Ability to work effectively in a team and independently - Knowledge of material management practices and procurement strategies (Note: No additional details about the company were provided in the job description.),
As an Officer Quality Assurance at the Human Resource Department of Sky Biotech, reporting to Mr. Prasad Kulkarni, the HR Manager, your role will involve the following responsibilities: - Perform QA Activities including Documentation, SOPs, IPQC Activities, and Process Control. - Coordinate with other departments such as Production, Store, Quality Control, and Engineering. - Establish Quality Systems to ensure compliance with standards and regulations. The qualification requirements for this role include: - 1-3 years of experience in a similar role. - Knowledge of QA processes and procedures. - Strong attention to detail and quality standards.,