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1.0 - 6.0 years
2 - 5 Lacs
Thane, Ambernath
Work from Office
1.0 Key or Primary Responsibility: Role & responsibilities 1.1 Line clearance for dispensing raw materials and manufacturing activities 1.2 Document issuance, distribution, retrieval, retention, and management 1.3 In process quality check for drug substance packing process 1.4 Distribution of SOPs, controlled copies of required documents to respective departments. 1.5 Coordination and timely completion of work as per management instruction. 1.6 To make documents controlled, uncontrolled, issuance, obsolete, execution and reference copies whenever required and update the tracking sheets as well. 1.7 To retrieve the executed documents from all departments and filing properly in QA document cell. 1.8 To prepare lists of documents retrieved from all departments and documents available in QA document. 1.9 Stamp management and maintaining properly under lock and key. 1.10 To arrange and label the files in QA document cell. 1.11 Preparation, coordination, and execution of vendor audit. 2.0 Secondary Responsibility: 2.1 Supporting the regulatory department for licensing activities 2.2 Issuance and retrieval of daily and monthly documents. 2.3 Controlling & distribution of the new SOPs to the respective departments, retrieving and destruction of the old-controlled copies of documents/ SOP's 2.4 Responsible for undergoing training in BGL policies and following BGL policies. Preferred candidate profile 3.0 Knowledge and skill set: 3.1 Effective communication skills and Good at Microsoft document editing 3.2 Ability to manage cross functional departments 3.3 Good in handling documentation
Posted 1 week ago
0.0 - 5.0 years
0 - 2 Lacs
Thane, Navi Mumbai, ambernath
Work from Office
Hiring for Customer Service Inbound and Outbound Shift : Day Rotationak Week off :1 Qualification : Hsc/Graduate Fresher Can apply Salary : Min 14.5k in hand to 20k in hand Age : Max 35 Regards, Pranali Kanojia Talent Acquisition 9324606566
Posted 1 week ago
2.0 - 5.0 years
3 - 4 Lacs
Thane, Ambernath
Work from Office
Role & responsibilities RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updation in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Preferred candidate profile Should have exposure to Formulation & Development of Injectable products knowledge for regulatory market preferable along with regulatory documents preparation like PDR, MFR etc. If having basic knowledge of injectable products is added advantage.
Posted 2 weeks ago
5.0 - 10.0 years
7 - 12 Lacs
Mumbai, Ambernath
Work from Office
Supervision of cleaning and calibration processes for equipments like electronic weighing balances, dispensing accessories, deep freezers, temperature sensors. Ensure the proper cleaning of packing materials, raw materials and Finished Goods storage areas. Ensure the cleaning procedures for various items like empty drums, hose pipes, flycatchers, Weighing Boxes, Standard Weights etc., Supervision of the receipt, storage, issuance, dispensing of raw materials, solvents, packing materials, and intermediate materials. Ensuring that FIFO/FEFO systems is followed during issuance, dispensing & storage of materials and specific requirements for hazardous or temperature / Humidity sensitive materials. Maintaining records for all raw materials received and issued, ensuring proper documentation like MRNs (Material Receipt Notes), logbooks, registers etc. Supervision of scrap/waste disposal activities in compliance with Standard procedures. Ensuring timely removal of waste from the warehouse and segregation of expired materials or those due for retesting. Supervising inventory management, including accurate weighing of materials, storage and issuance to production department as per material requisition slip. Preparing and maintaining dispatch records and performed the activity as per SOP procedures. Ensuring the stored material as per prescribed condition and maintain storage manual and records. Monitor the inspection activity of outdoor storage solvent drums, handling of retest/expiry material, handling of rejected material procedures, Return material, Intermediate Storage room, Temperature Mapping, EHS aspects. Provide the induction to joining the new employees. To ensure and provide the training to new employees as well as contract workers for handling & storage of materials. Implementing and ensuring the adherence to SOPs related to handling of materials, equipments and cleanliness. Reviewing and overseeing the implementation of corrective actions for deviations, incidents etc. Ensuring compliance with Regulatory Requirements and Quality standards in Inventory Management. Participating in investigations of complaints, deviations, Out of Specifications, incidents or any non-conformances, performing the root cause analysis and implementing corrective actions to prevent recurrence. Involve in mock recall procedures provide the list of customers/agents, contact details, reconciliation of materials of API batches / recalled batches and managing the recall of APIs, including documentation, labelling and storage etc. Leading a team to ensure the smooth operation of warehouse activities. Supervising the activities of various teams, including cleaning, material handling, storage and inventory management. Ensuring effective communication and timely execution of tasks within the team and cross-functional departments. Change Control reviewing and assessing the impact of proposed changes on standard practices whether in process, equipments or issuance of material to ensure that changes are appropriately executed. Evaluating repetitive deviations and taking steps to address systemic issues. Ensuring that data integrity is maintained in all warehouse activities, highlighting any potential data issues for further investigation. Participating the customers and Regulatory Audits and providing the compliances as per guidelines. Knowledge of GMP inventory management Good documentation practices Dispatch and logistics coordination Attention to detail, team coordination skills
Posted 2 weeks ago
3.0 - 5.0 years
2 - 5 Lacs
Thane, Ambernath
Work from Office
Developing and validating analytical methods for the development of new and existing products Preparation and execution of method validation protocol and report. Designing and executing experiments to develop and validate analytical methods. Documenting and interpreting the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Ensuring compliance with safety regulations.
Posted 2 weeks ago
5 - 10 years
3 - 6 Lacs
Dombivli, Ambernath, Badlapur
Work from Office
Our client which is into high-quality Automotive & Industrial lubricants is looking for : Business Development Manager Profile: Make outbound calls to companies and potential customers Explain company's spare blending and filling services to client Required Candidate profile Need Based Visit at the Potential Customers Maintain the database of customers & leads Follow up with leads & convert into business Should have B2B Sales experience Whatsapp your CV on : 8422074660
Posted 1 month ago
3 - 5 years
2 - 5 Lacs
Thane, Ambernath
Work from Office
Developing and validating analytical methods for the development of new and existing products Preparation and execution of method validation protocol and report. Designing and executing experiments to develop and validate analytical methods. Documenting and interpreting the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Ensuring compliance with safety regulations.
Posted 3 months ago
3 - 5 years
3 - 8 Lacs
Navi Mumbai, Ambernath
Work from Office
Conduct outdoor sales Identify new business opportunities. Drive revenue from strategies. Build strong client relationship. Attend industry events for networking. Use CRM & sales tools effectively. Call:9136645433 Note: Only male candidate required
Posted 3 months ago
8 - 13 years
12 - 18 Lacs
Mumbai, Ambernath
Work from Office
JOB SUMMARY: 1. Formulate and ensure implementation of organisational strategy in line with Departmental strategy. 2. Develop KPI in line with organisational strategy focussing on goals of the department. 3. Coordinate, formulate and implement standard operating procedures for purchase. Adhere to purchasing policy as per guide lines of SG 4. Investigate alternate sources for critical raw materials & engineering spares 5. Analyze purchase and financial risks involved well in advance and take adequate measures to mitigate the same 6. Identify training/learning needs of subordinates and provide opportunities for development 7. Ensure key supplier audit is carried out at periodic intervals and assess vendor capabilities, based on the observations 8. Improve "ONTIME" by ensuring material availability as per production plan. 9. Comply with all QMS/EHS systems 10. Implement digitalisation procurement process as per the SG purchase requirements
Posted 3 months ago
4 - 5 years
5 - 8 Lacs
Mumbai, Ambernath
Work from Office
The Biotech Laboratory Specialist will ensure that all activities within the department align with current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). This role is critical for managing and performing a range of laboratory techniques, including PCR, ELISA, Capillary Electrophoresis, Isoelectric Focusing, Western Blotting, and Flow Cytometry. The specialist will also be responsible for preparing and executing method validation protocols and reviewing routine analysis reports. Experience with Quality Management Systems (QMS), particularly LIMS and EQMS, is essential. Key Responsibilities: Laboratory Techniques: Perform Polymerase Chain Reaction (PCR) assays for molecular analysis. Conduct Enzyme-Linked Immunosorbent Assay (ELISA) tests for biochemical assays. Operate and maintain Capillary Electrophoresis and Isoelectric Focusing systems. Execute Western Blotting and Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE) techniques for protein analysis. Perform Flow Cytometry for cell analysis and sorting. Conduct other biochemical and molecular biology tests as required. Method Validation: Develop and prepare method validation protocols to meet regulatory and internal standards. Execute validation procedures in accordance with regulatory guidelines and company practices. Accurately document and report validation results in a timely and comprehensive manner. Report Review: Review routine analysis reports to ensure accuracy, compliance with quality standards, and adherence to regulatory requirements. Identify and investigate any discrepancies or deviations in data, ensuring proper corrective actions are taken. Quality Management Systems: Maintain and manage Laboratory Information Management Systems (LIMS) for effective sample tracking and data management. Support and contribute to the Electronic Quality Management Systems (EQMS) to enhance and maintain laboratory quality processes. Ensure compliance with internal quality standards and regulatory guidelines at all times. Experience & Qualifications: Experience: 4-5 years of hands-on laboratory experience in a biotech or pharmaceutical setting. Education: Masters degree in Biotechnology or a related field. Key Skills: Expertise in PCR, ELISA, Capillary Electrophoresis, Isoelectric Focusing, Western Blotting, SDS-PAGE, and Flow Cytometry. Strong understanding of method validation and documentation. Familiarity with LIMS and EQMS systems. Knowledge of cGMP and cGLP requirements. Excellent attention to detail and strong problem-solving abilities. Work Schedule: Flexibility to work in 1st , 2nd , and General shifts as required. Additional Requirements: A proactive approach to quality and compliance, with a commitment to improving lab efficiency and accuracy. Ability to handle multiple tasks and meet deadlines in a dynamic, fast-paced environment.
Posted 3 months ago
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