ApplusVelosi

Microbiological Testing: Perform microbiological tests such as bioburden sterility endotoxin (LAL test) and microbial limits for raw materials water and finished products. Environmental Monitoring: Conduct routine viable and non-viable particulate monitoring surface swabbing settle p المزيد...

Machine Operation: Operate auto coating machines (like Gansons Neocota Accela Cota) for film and enteric coating of tablets. Batch Execution: Execute coating operations as per Batch Manufacturing Records (BMRs) and defined process parameters (spray rate pan speed inlet/outlet tempera المزيد...

Operate granulation equipment such as:Rapid Mixer Granulator (RMG)Fluid Bed Dryer (FBD)Multi MillSifterVibro SifterHigh Shear Mixer (if applicable)Ensure correct batch processing according to Batch Manufacturing Record (BMR).Accurately weigh and charge raw materials into the equipment المزيد...

Machine Operation: Independently operate Brevetti visual inspection machines for sterile ampoules/vials. Inspection Monitoring: Monitor product quality for particulate matter breakages cosmetic defects improper sealing and other abnormalities. Setup & Changeover: Perform machine المزيد...

Manufacturing Investigations: Lead and guide root cause analysis (RCA) for deviations batch failures OOS/OOT results and ensure implementation of robust Corrective and Preventive Actions (CAPA). Complaint & Recall Handling: Manage market complaint investigations initiate product المزيد...

To prepare Qualification documents of newly installed machines/equipments instruments & systems with co-ordination of User department & QA department.To prepare the qualification & re -qualification documents for HVAC systems or utility machines & other plants mac المزيد...

1. Toensure cGxP compliance in the laboratory.2. Media preparation sterilization and GPT of media.3. MET of Samples (FG RM INPROCESS HOLD TIME SWAB sample and STABILITY)4. Environment monitoring in production Sampling Area and microbiology section (By Settle Plate & Air Sample المزيد...

Method Validation: Execute analytical method validation and verification for raw materials in-process samples and finished products in line with ICH Q2(R1) guidelines. Method Transfer: Support analytical method transfer activities from R&D or other manufacturing sites including e المزيد...

Machine Operation: Operate auto coating machines (like Gansons Neocota Accela Cota) for film and enteric coating of tablets. Batch Execution: Execute coating operations as per Batch Manufacturing Records (BMRs) and defined process parameters (spray rate pan speed inlet/outlet tempera المزيد...

1. Responsible for troubleshooting of all engineering equipments like Process Packing ASRS etc.2. Execute preventive and breakdown maintenance of all facilities and equipment as per schedule.3. Attend all types of breakdowns like Electrical Instruments Mechanical etc and conduct initi المزيد...

Sample Analysis: Perform chemical and instrumental analysis (e.g. HPLC UV Dissolution Titration) of finished dosage forms like tablets capsules and injectables. Pharmacopoeial Testing: Ensure compliance with USP BP IP Ph. Eur. standards during analytical procedures. Documentation: Pr المزيد...

Machine Operation: Operate and monitor granulation equipment such as RMG (Rapid Mixer Granulator) FBD (Fluidized Bed Dryer) Multi Mill and Sifter. Batch Execution: Execute granulation activities as per BMR and production planning ensuring material flow and process control. In-Process المزيد...

Sampling & Analysis: Conduct chemical and instrumental analysis (e.g. HPLC GC UV FTIR wet chemistry) of raw materials following SOPs and pharmacopoeias (IP BP USP ). Documentation: Prepare and review raw data sheets COAs logbooks and test reports ensuring accuracy and compliance المزيد...

QC-Planning / Review and Compliance-QC Planner for the section of all sections (FP-IP / Stability /Validation / PM/RM/stability.-Ensure timely completion of analysis by overseeing accurate laboratory testing through regular floor checks and review of reports/ results/ COA.-Daily updat المزيد...

Batch Execution: Supervise and execute blister packing bottle filling labeling and cartoning operations as per batch planning. Line Clearance & Setup: Ensure proper line clearance machine setup and material availability before starting each batch. In-Process Checks: Perform and r المزيد...

GLP Compliance Monitoring: Ensure all QC activitiesincluding sample handling testing equipment usage and result recordingadhere to GLP guidelines. Documentation Review: Review logbooks worksheets calibration records test reports and analytical data for accuracy and traceability. Devi المزيد...

Operate Granulation Equipment:Set up operate and monitor granulation machinery (e.g. high-shear mixer fluid bed dryer oscillating granulator).Ensure machines are functioning efficiently and safely during production runs.Batch Processing:Follow approved batch manufacturing records (BMR المزيد...

Document Review: Review analytical test reports raw data chromatograms stability reports and logbooks for accuracy and compliance. Deviation & OOS Handling: Support investigation and closure of OOS OOT deviations and lab incidents ensuring implementation of CAPA. Audit & Comp المزيد...

We are seeking an experienced and dynamic Head of Microbiology to lead our microbiology department. The ideal candidate will have a strong background in microbiological testing regulatory compliance and team management. This role is critical for maintaining high-quality standards and المزيد...

Conduct Analytical Testing: Perform routine analytical tests including HPLC UV and titrations on raw materials in-process samples and finished products ensuring adherence to standard operating procedures.Follow GMP & GLP Guidelines: Ensure compliance with Good Manufacturing Practi المزيد...