449 Process Validation Jobs - Page 10

BMR Review, BPR Review, Line Clearance, Change Control, Deviation.

To follow safety rules in the premises according to the company norms. Operation and Cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. To ensure cleaning and storage of change parts as per the procedures. To maintain the BMRs and other log books in the compounding area as per cGMP and SOP Cleaning and maintenance of compounding area as per GMP and SOP Operation and cleaning of dynamic pass box in compounding area Responsible for Cleaning and sanitization of drain points in compounding area Responsible for manufacturing and supervising ...

Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of...

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech T...

•Drive continuous process improvements on the assembly line to enhance productivity and reduce risk •Prepare and maintain PPAP documentation Control Plans, PFMEA, Check Sheets, etc.) •Apply quality tools and methodologies such as APQP and 7QC tools

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process V...

MISSION To lead the industrialization of the new P1 To improve the production efficiency (machine & Direct Labor) in its perimeter Capitalize and share the know-how of industrial processes in his domain To participate on the design of new equipment and new lines To lead Lean design workshop Industrialization To manage production equipment introduction using IPROM To follow equipment or assembly lines development with the supplier To design small tool and validate the supplier proposal To define the acceptance criteria for new equipment or line To perform pre acceptance and acceptance of the equipment To perform trials on the lines and deliver reports To built action plans and follow up to be...

Job Description Rev. no.: 00 Followings will be the responsibilities of the position holder: 1. Act as receiving team for new and reformulated product from I&D to AHPL Baddi. 2. Scale up/scale down for new and existing products. 3. Preparation of MMD of new and existing products. 4. Review of sampling plan for engineering & process validation. 5. Technical inputs for product improvisation w.r.t equipment and process, formulation, or shelf-life changes through appropriate QMS. 6. Handling of reprocessing, reworking of existing formulation. 7. To support for failure investigation or exceptions (as per applicability) OOS/OOT observation. 8. All documentation & process steps for trial/non-commer...

Job Description Executive IPQA M. Pharma/ B. Pharma. Minimum 5 Years Experience in solid dosage form- Tablets (Hormone) Person shall be well versed with manufacturing and packaging operations, Compression Machines, Isolators, Blenders, Bulk packing lines, & Process Validation. Person with Experience in Hormone Facility shall be preferred. Followings will be the responsibilities of the position holder: Ensure compliance to cGMP Regulations, established SOPs, FO/MI and PO/PI and for all operational activities, area and equipment. Perform QA review of executed batch production records and ensure the submission of Batch production record in the document cell. Calibration & maintaining documentat...

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Scheduling the work plan in consultation with group leader/ reporting authority for timely completion of the projects based on priority assigned. Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation of t...

1.Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments. 2.Resopnsible for investigation of LIR (Incident / OOS/ OOE). 3.Analysed data review. 4.Analysis of Finished, In process, Process validation, Cleaning Validation samples. 5.To report any OOS/Incidence results to immediate supervisor/Head of department.

Followings will be the responsibilities of the position holder: 1. Act as a receiving team for new and reformulated product from I&D to AHPL Baddi. 2. Scale up/scale down for new and existing products for review the occupancy in RMG and Blender. 3. Preparation of MMD of new and existing products. 4. Review of sampling plan for engineering & process validation. 5. Technical inputs for product improvisation w.r.t equipment and process, formulation, or shelf life changes through appropriate QMS. 6. Handling of reprocessing, reworking of existing formulation. 7. To support for failure investigation or exceptions (as per applicability) 8. All documentation & process steps for trial/non-commercial...

Testing of Raw Materials , Finished samples , In process Samples and process validation ,using current pharmacopoeias, Standard Test Procedure and Specifications. Supporting all QC activities. To ensure that Equipment/Instrument in the QC Department are qualified, calibrated and under regular schedule of calibration as per SOP. Reporting to Quality Head. Preparation of test solutions, compounds and reagents for laboratory personnel to conduct test. Sampling of Raw Material as per SOP

Executive-CQA Long Description 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation Work Experience 5 - 8 years

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

Job Description Responsible for Toxicological assessment of genotoxic and nitrosamine impurities. Responsible to support the development of nitrosamine and other genotoxic impurity risk assessment and carryover limits. To support the site management team in reviewing cleaning, nitrosamine and genotoxic impurity and keep sites up to date according to current regulatory requirement /expectation. Reviewing Permissible Daily Intake, Occupational Exposure Limits, Toxicological Justification, Quality Risk Assessment document. Responsible for preparation and revision of corporate procedures like SOP related to the assessment of potential carryover or cross-contamination of genotoxic/carcinogenic im...

Job Description Batch Manufacturing and Filling activity. Batch manufacturing experience of Solution, Emulsion, suspension and gel eye drop products. Preparation and review of Deviation investigation, Risk Assessment, Impact Assessment, Equivalency reports, URS and various other production related documents and monthly intervention reports. Responsible for audit preparation (Internal and regulatory) and compliance. Reconciliation of product at various stages of batch manufacturing and filling. Preparation and reviewing of SOP and compliance after implementation. QAMS related activity. Approved GMP trainer for provide training to team members. Preparation of Media fill BMR. Planning for produ...

BD & provide technical support. Handle Multistep Synthesis. Peptides Synthesis using Solid Phase Peptide Synthesis. Design & synthesis of small molecules in API. Handling synthesis of organic chemical reactions.Knowledge on Instrumentation is a must. Annual bonus Provident fund Health insurance

Division Department Sub Department 1 Job Purpose To execute the activities that are related to microbiology laboratory. Key Accountabilities (1/6) I. Involvement in all quality related activities. Maintenance of all the area and the equipment. To ensure and monitor compliance with GLP and cGMP as per requirements of the respective authority. Key Accountabilities (2/6) II. Environment monitoring Monitoring of area to be carried out as per allocated schedule. Release and transfer within the timeframe mentioned in SOP. Follow the written procedure for Execution of aseptic process validation and testing of Aseptic process validation sample. Involvement in process Simulation. Key Accountabilities...

As a Solution Tester, you will be responsible for: 1. Designing and automating test suites to ensure reliability of the system z(s390x) platform technology 2. Having a client-first mindset to test at scale and imitate customer-like environments 3. Creating strategies and scripts to test new features and functionalities 4. Contributing and reviewing code for internal and external repositories 5. Documenting processes (Test plans) and procedures for clarity and reproducibility 6. Interacting with counterparts in US/Germany teams and Red Hat Required education Bachelor's Degree Required technical and professional expertise Required Technical and Professional Expertise with relevant experience o...

We are looking for an experienced and detail-oriented Quality Assurance (QA) professional to oversee and maintain the quality management system and ensure compliance with statutory and customer standards. Responsibilities: Prepare and maintain all quality manuals, process documents, and standard operating procedures (SOPs). Review and approve process, quality control, maintenance manuals, and batch/lot releases. Investigate deviations, failures, non-conformances, out-of-specification results, and customer complaints; implement corrective and preventive actions (CAPA). Ensure calibration and maintenance of all instruments and test equipment used for inspection and testing. Ensure compliance w...

Role & responsibilities 1) Engineering daily round and document verification in order to compliance. 2) Verification of Calibration planner, preventive maintenance planner to ensure activity done as per scheduled plan. 3) GPS clock time verification across the plant as per schedule, Alarm verification of equipment as per planner. 4) Audit trail verification of equipment (Drug product & Engineering area). 5) Review of memo in system and ensure closure in time with coordination to cross functional team with proper evaluation. 6) Preparation / review of Media fill protocol and report. 7) Preparation of process / cleaning validation protocol & report. 8) Review of cross functional documents (SOP...

Responsibilities: * Conduct BPR reviews, change control procedures & equipment validation. * Ensure compliance with industry standards through quality assurance processes.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...