274 Jobs in Dholka - Page 4

Core responsibility related to GLP: Anesthesia / euthanasia of laboratory animals as per SOP Blood collection preparation Collection of blood from laboratory animals as per SOP and study plan Preparation of blood smears Necropsy & organ collection from laboratory animals (rat, mice, rabbit & guinea pig). Preparation of fixative solutions. Tissue sectioning and maintaining various histopathological instruments. Labeling of micro centrifuge and bottle according to study plan. Preparation of surgical instruments for necropsy. Opening of carcass and collection of organ according to study plan requirement. Tissue trimming according to SOP and study plan requirement. Processing of animal tissue ac...

Role: Research Associate, Bioanalytical Experience: 0 to 3 Years Location: Dholka(Near to Ahmedabad), Gujarat, India Qualification: B. Pharma/M. Pharma/M. Sc 1. LCMSMS operation, maintenance and calibration 2. Method development, Validation and study sample analysis as per guidance 3. Documentation as per GLP and GDP 4. Internal calibration and performance check of instruments

- Analytical Method Development and Method validation by LC-Mass for all API Project. Prepared MOA, Protocol and that basis execute the validation and finally prepared the report - Tuning the system, API, and select the MRM - Plant Release sample and plant cleaning sample analysis by LC-MSMS, fill up TDS, and submitted COA at Ankleshwar QC - Routine LC-Mass Analysis for Intermediate, in process and Final API as per the Specification and Standard test procedure - Calibration of LC-Mass system and prepared report - To maintain GLP in working environment - Regularly requirements co-ordination with project scientist - Preparation of analytical data and submit to concern project scientist - Co-or...

1. Strategic Sourcing & Procurement Develop and implement procurement strategies aligned with business objectives. Manage sourcing of raw materials, packaging materials, and indirect purchases for multiple locations. Ensure timely procurement while optimizing cost, quality, and delivery timelines. 2. Vendor Development & Management Identify, evaluate, and develop reliable suppliers (domestic & international). Negotiate contracts, pricing, and terms with vendors to secure favorable terms. Conduct periodic vendor audits in coordination with QA/QC to ensure compliance. 3. Budgeting & Cost Control Prepare annual purchase budgets and monitor adherence. Analyze market trends and pricing to control...

Follow cGMP and GLP practices in Quality Control Lab. To analyze the Sample of In process validation and finish product on non-chromatographic instrument such as FTIR, UV, Dissolution, DT , Hardness etc by following test procedure. To attend the training as per schedule. To follow safety procedure in qc department. To receive the samples for analysis and making entry in Inward register. To maintain the Instruments log books related to sample analysis. To analyze the sample and compilation of documents. Responsible for taking of Continuations sheet (CS) and print out Record of analysis (ROA) through LIMS. Responsible for cleaning & monitoring of laboratory. Responsible for online documentatio...

To lead the technology receiving activities and QMS related activities at manufacturing plant. To lead technology-receiving activities to receiving processes from upstream process development to manufacturing and/or between multiple manufacturing sites. This includes developing and maintaining key SOPs, manufacturing records to support compliance with quality management and regulatory submissions. To lead alternate vendor batch execution, process improvement, change in batch size, troubleshooting at shop floor, equipment change activities of product after technology transfer completion along with production team. To coordinate the development of the manufacturing process with the R&D by keep...

1. To develop Stable & Bioequivalent for solid oral products for Europe, ROW & Domestic Markets. 2. Technology transfer of developed products to plant level, this includes all TTD-related works. 3. To collect and compile all data and submit to respective regulatory agencies. 4. To address DCGI/ regulatory agency queries as per requirement. 5. To extend support to plant for any commercial trouble shooting.

To prepare and maintain SOP and documents related to Plant preventive maintenance. To conduct routine breakdown maintenance of Main Pharma Block equipment's. To follow and implement PPM schedule for effective implementation in shortest duration of time for all equipment's in close co-ordination with production dept. To allocate maintenance job to all the technicians with routine breakdown requisition. To co-ordinate with inter department staff for any breakdown or any abnormality in equipment's. To provide support to Execution of CAPEX project of process equipment side. Ensure timely indenting of spares required for preventive maintenance / breakdown maintenance with close follow up with sen...

To operate the CVC Bulk packing machine as per the norms of cGMP To supervise the machine activity as per the standard output with GMP requirements To carryout in process checks during packing machine activities To arrange packing materials as per shift plan & planning for next shift packing materials To minimize the rejections during packing operation To maintain online and offline packing activity along with time management To ensure timely transfer of finished goods to the BSR

To perform In-process Quality Assurance for the process / products being manufactured and packed in Main Pharma Block (Tablet / Capsule). To ensure Quality and cGMP compliance of the products being manufactured and Packed in Main Pharma Block (Tablet/Capsule). To give area and machine clearance i.e. checking and approval of processing areas and Equipment's prior to start of batch processing. To verify environmental conditions i.e. Temperature, Relative Humidity & Differential Pressure conditions are within acceptable range in all areas. To perform and verify challenge tests at manufacturing and packing stages as per the pre-defined frequency. To verify the status of calibration and preventiv...

Manages active medium projects with minimal assistance from Management. Resolves project issues and resource constraints within the team and with moderate assistance. Facilitates positive team member interactions and manages conflict with minimal assistance. Establishes/practices standard project reporting procedures to client and management (i.e. minutes, agendas). Plans, monitors and ensures completion of all activities outlined in the project management tracker for each project. Maintains very good relationship with internal and external stakeholders and grow it positively. Proficient in MS Office, Outlook, Project Management tools.

Develop and execute a strategic vision and roadmap for the biologics R&D portfolio Identify and prioritize research areas with high potential for innovation and commercial impact Oversee the planning, execution, and completion of R&D projects, ensuring they meet scientific rigor and regulatory requirements Ensure projects are progressing as planned and address any issues or challenges proactively Collaborate effectively with cross-functional teams, including Research, Quality, Manufacturing, Finance and Regulatory affairs Lead, mentor, and develop a team of scientists and researchers, fostering a culture of innovation and collaboration Manage and allocate resources effectively to ensure proj...

Major Purpose of the job: 1. Preparation of New product specifications and standard test procedures for ANDA, Export and Domestic Markets 2. Preparation of Routine revision specifications and standard test procedures for ANDA, Export and Domestic Markets Principal tasks & responsibilities: 1. Preparation of new product documents and routine revision of raw material specifications and standard test procedures for Export, regulatory agency and Domestic market 2. Preparation of new product documents and routine revision of finished product specifications and standard test procedures for Export, regulatory agency and Domestic market 3. Preparation of specification and standard test procedures fo...

- Planning and execution of In-process, Bulk and finished product and Stability analysis of all recombinant proteins using different analytical techniques: HPLC, Protein quantification, Gel electrophoresis, Western blot and Dot blot, ELISA - Protein expression and characterization analysis by HPLC for different recombinant vaccines projects. - Analytical method development and Validation for recombinant vaccines as per guidelines. - Data compilation, evaluation and report preparation for the all experiments conducted. - Maintenance of Lab equipment and preparation of reagents for analysis related work. - Documentation as per GDP guidelines. - Training of colleagues & trainee

To set & achieve the daily targets to achieve monthly targets. Trace the daily output of equipment with respect to the daily target and intimate the deviation with justification in OEE report. To co-ordinate with cross functional departments (i.e. Dispensing, Granulation, Compression) for input material and co-ordinate with WIP, packing, QA, QC for sampling and release to packing. To ensure the SAP transactions of completed products. To ensure the cleanliness of area & equipment and to ensure the equipment parts, change parts are place at designated location with proper status labelling. Ensure the procedures are followed as per Standard operating procedure and continuous improvement in syst...

Liaison with regulatory authorities/government bodies, coordination with customers/consultants - DGCI and India Regulatory bodies Provide regulatory advice to cross functional departments right from the development stage leading to a scientifically sound regulatory submission within committed project timelines Provide regulatory inputs and frame up strategy of regulatory submission during business development discussions with international customers and International Marketing Division Guidance to regulatory/quality team to perform their respective functions efficiently and accurately. Identify team member's capabilities to perform and assign additional responsibilities accordingly. Adopt th...

Responsible For rDNA manufacturing and Parenteral mfg activities at Dholka premises To ensure personal hygiene of the workmen before entering to aseptic area and maintain record. To check and ensure that aseptic area workmen are following entry exist procedure properly. To check and ensure that differential pressure, RH and temperature of the aseptic area and mfg area are within limit and record it properly. To check and ensure that differential pressure of all Laminar Air Flow are within limit and record it properly. To check on line in process parameters like temperature, RH, fill volume, quality of sealing at specific interval as mentioned in respective MMDI and SOPs and record the same i...

To perform In-process Quality Assurance for the process / products being manufactured and packed in Main Pharma Block (Tablet / Capsule). To ensure Quality and cGMP compliance of the products being manufactured and Packed in Main Pharma Block (Tablet/Capsule). To give area and machine clearance i.e. checking and approval of processing areas and Equipment's prior to start of batch processing. To verify environmental conditions i.e. Temperature, Relative Humidity & Differential Pressure conditions are within acceptable range in all areas. To perform and verify challenge tests at manufacturing and packing stages as per the pre-defined frequency. To verify the status of calibration and preventiv...

Responsible for small volume parenteral manufacturing activities at Dholka premises. To check hygienic condition of the workmen before entering to aseptic area, processing area and compounding area and maintain record. To check and ensure entry exist procedure of workmen with proper gowning and sanitization. To check and ensure that Temperature and differential pressure of the all area is within limit and record it properly. To check on line in process parameters like temperature, RH, fill volume, quality of sealing at specific interval as mentioned in respective MMD-I and SOPs and record the same in BMR To check and ensure that sterilization of the containers, equipment's, utensils etc. are...

Job Summary: We are looking for a highly motivated and enthusiastic HR Trainee to join our Human Resources team. This role is ideal for recent graduates or students pursuing a degree in HR, Business Administration, or a related field who are looking to gain hands-on experience in a dynamic HR environment. Key Responsibilities: Assist in employee engagement initiatives Support onboarding and induction of new employees Maintain and update employee records and HR databases Assist in organizing training and development activities Help in updating HRIS information in tool, drafting HR documents, letters, and reports Participate in employee engagement and welfare activities Ensure compliance with ...

1. To develop Stable and Bioequivalent solid oral products for US, Europe, ROW and Domestic Markets. 2. Technology transfer of developed products to plant level, this includes all TTD-related works. 3. To collect and compile all data and submit to respective regulatory agencies. 4. To address DCGI/ regulatory agency queries as per requirement. 5. To extend support to plant for any commercial trouble shooting.

Operation and cleaning of respective compression machine hand over by shift in charge or any supervisor of compression area as per SOP. Maintain the compression area with compression machine as per auditable requirement and as per SOP. Report in shift as per shift schedule prepared by respective supervisor or manager. Labelling and weighing activity performed as predefined procedure and SOP. Online documentation & in process checks entry in respective batch manufacturing record and respective documents as per SOP. Operation, cleaning and maintain compression machine, Metal detector, Dedusting unit, ADU, weighing balance and other IPQC instrument as per SOP. Cleaning, Handling and maintain th...

1) Based on production requirement generate the production plan for next 3 month. 2) Run MRP for next 3 month in System (SAP) 3) Share the shortages to RM / PM based on requirement to Purchase team. 4) Discuss and coordinate with purchase team for timely supply RM / PM 5) Discuss with Production team for scheduling of products. 6) Delivery has to completed for M0 for ISBU / USBU on 22nd and for BSBU on 25th 7) Prepare the plan Vs Actual on daily basis. 8) Generate the LL requirement separately after discussion with LL team. 9) Closely coordinate with cross function department for Ach goal. 10) Daily discuss with Production / QC and purchase team for ach daily schedule. 11) To provide technic...

Responsibilities: 1. To ensure the delivery of products as per the production target. 2. To ensure and monitoring yield, Wastage, WIP & operation expenses of compression area. 3. To co-ordinate with tablet sub- department, Quality Assurance, Quality Control and engineering department to achieve production delivery as per production schedule. 4. To ensure daily production report and submit to higher management. 5. To ensure periodic qualification of equipment and process validation are carried out as per schedule. 6. Raise the change control for new equipments installation and completed the I.Q, O.Q and P.Q of new equipments. 7. Raise the deviation for unplanned or any incident base activity ...

1. Act as a Study personnel for various pre-clinical studies as per various regulatory guidelines and GLP regulations. 2. Handling and dosing of various laboratory animals like Rat, Micek, Rabbit, and Guinea pigs. 3. Conducting of pharmacological evaluation of various pharmaceutical products. 4. SOP preparation and documentation as per GLP regulation. 5. Maintaining facility for regulatory and sponsor's audit.