879 Process Validation Jobs - Page 7

As a Validation Specialist, your role involves reviewing URS, DQ, and vendor/suppliers documents related to qualification. You will be responsible for preparing and reviewing Validation/Qualification protocols and reports. Your duties also include executing and reviewing Qualification/Re-Qualification and Validation activities of Equipment/System/Facility and Plant utilities. Coordinating with manufacturing, Engineering, and QC personnel for timely completion of Qualification/Validation/Re-qualification activities is a key aspect of your role. Additionally, you will be preparing and reviewing media fill and hold time protocols and reports. Your responsibilities extend to preparing Standard O...

Role Overview: You will be working as a SME Hard Machining Expert (Grinding and Honing and Hard Turning) at SKF's Ahmedabad Manufacturing Plant. Your main responsibility will be to drive process improvements, support new product development, and ensure smooth execution of grinding and honing operations during the factory expansion phase. Key Responsibilities: - Serve as the technical expert for grinding and honing operations during the factory expansion phase. - Lead the installation, commissioning, and validation of new grinding and honing machines and channels. - Define and optimize process parameters to meet quality, productivity, and cost targets. - Conduct process trials, capability stu...

Job Description Key Responsibilities: Responsible for review of URS, DQ and vendor/ supplier's documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedur...

JD for Asst. Manager QA (Section Head : Validation and Qualification) Qualification : B Pharm/ M. Pharm Experience : 6 to 10 years. J ob Responsibilities Ensure compliance of all procedures, practices and system to cGMP with respect to Schedule M., WHO guidelines, Abbott Quality guideline and Standard operating procedures at site. Responsible for execution of Equipment and Instrument Qualification. Responsible for execution of Process validation and Cleaning validation. Should have knowledge of QMS activities. To perform acceptable quality level. Responsible for User management, Audit trail review of Production instruments. To deliver the training at site on GMP topics, SOPs and other techni...

Experience : 5.00 + years Salary : Confidential (based on experience) Shift : (GMT+05:30) Asia/Kolkata (IST) Opportunity Type : Hybrid (Chennai) Placement Type : Full time Permanent Position (*Note: This is a requirement for one of Uplers client - Aletha Health) What do you need for this opportunity Must have skills required: Quality Control, Quality Assurance, ISO 13485, ISO 14971, ISO 2859-1, Polymer Testing Aletha Health is Looking for: Role Summary We're seeking a hands-on Senior QA/QC Engineer to build, run, and continually improve our medical device quality system, with a strong focus on plastic components and assemblies. You'll own incoming/in-process/final quality, validation and tes...

Role & responsibilities Validation & Qualification of Equipment Experience in Autoclave, Terminal, Sterilizer, Mixing Vessel, Tunnel Qualification, washing machine and filling machine. HVAC Qualifications Validation and qualification protocol and report. To ensure material issuance for validations activities & keep Section Manager updated. To ensure implementation of validation, qualification activities & inform to Section Manager for any deviation from written procedure. Equipment Qualification Steam Heat Sterilizer, Terminal sterilizer, Preferred candidate profile:- Result orientated Communication skills Presentation skills Analytical skills Lateral coordination * Candidate can share their...

Role & responsibilities Validation & Qualification of Equipment Experience in Autoclave, Terminal, Sterilizer, Mixing Vessel, Tunnel Qualification, washing machine and filling machine. HVAC Qualifications Validation and qualification protocol and report. To ensure material issuance for validations activities & keep Section Manager updated. To ensure implementation of validation, qualification activities & inform to Section Manager for any deviation from written procedure. Equipment Qualification Steam Heat Sterilizer, Terminal sterilizer, Preferred candidate profile:- Result orientated Communication skills Presentation skills Analytical skills Lateral coordination * Candidate can share their...

QC & Formulation Development – Dental Products Person with hands-on experience in testing and developing dental materials such as powders, gels, pastes, cements, composites, and resin-based systems, includes QC testing, formulation trials, method Required Candidate profile Conduct QC tests, evaluate materials, support formulation development, run lab trials, follow ISO standards, prepare documentation, and coordinate with QA, R&D, and Production for batch and scale-up.

Role & responsibilities Design, implement, and optimize processes for new and existing products Develop and execute process validation protocols Collaborate with cross-functional teams to ensure product quality and regulatory compliance Troubleshoot process issues and implement corrective actions Develop and maintain process documentation, including SOPs and batch records Identify opportunities for process improvement and implement changes Support scale-up and technology transfer activities Ensure compliance with cGMP, regulatory requirements, and company policies Development of new product, improving the existing product and process in R&D lab. • Interaction with the R&D development team fr...

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how the Technology Transfer - Research Scientist/ Senior Research Scientist /Tea...

We are looking for candidate expertise in Quality Assurance mainly handling below responsibilities. If your expertise matches with the requirement kindly share your CV at swathi.p@smt.in. Job Title : Officer/Sr Officer Functional Area : QA Key Accountabilities Technical and QMS Documentation: Preparation and Review of Documents as per ISO 13485, EU-MDR, 21CFR820, Thai FDA and Indian Medical Device Rule and ensure implementation of same. Handling of Deviation, Non-Conformance, Change controls and CAPA. Handling of Post market surveillance Preparation of the regulatory documents (TMF/Dossiers) for regulatory submission. Preparation of Technical files in co-ordination with R&D Team. Preparation...

Job Title: Deputy Manager- Formulation Location: Govandi, Mumbai Working Days: Monday to Saturday(2nd and 4th Saturday off, 1st,3rd and 5th Saturday operational) Department: Corporate Quality Assurance Qualification, Experience and Technical Competency: 1. Masters Degree in Pharmacy or Science or equivalent scientific field. 2. Minimum 10 years experience in Pharmaceutical Industry (Strong background of Formulation industry with 2 to 3 years experience in Quality Control.) 3. Work experience in Regulatory Sites (USFDA, MHRA, EU GMP) 4. Knowledge of current Good Manyfacturing Practices (cGMP), Quality Management Systems (QMS) and regulatory guidelines. Key Requirements: Responsible for Qualit...

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Responsibilities: * Collaborate with cross-functional teams on process improvements * Conduct IPQA activities during product development * Ensure compliance with regulatory requirements Annual bonus

Monitoring of Loan Licence Site located in Palghar & Vadodara region. IPQA/Shop floor activities monitoring - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. (Preferred Tablets, Capsules, Oral Powder formulations) Quality Oversight at Loan Licence Sites and tracking for closure of actions. FG Inspection, Review of batch records and Batch releases. Site pre-assessment for regulatory inspections as per GMP requirement. Investigation of any non-compliance in co-ordination with LLU Site and tracking closure of CAPA. Review and COA and analytical data before release of finished product from LLU Site. Review of Finished product related data to support new product Launch. Pr...

Monitoring of Contract manufacturers of Consumer products across India. Quality Oversight at Contract manufacturing sites of Consumer products. Overall responsible for monitoring of Quality compliance at Consumer Sites across India. FG Inspection, Review of batch records and Batch releases Review of Finished product related data to support new Third Party Launch Monitoring of all shop floor activities IPQA Checks of Consumer products Lozenges, Toothpaste, Food, Nutraceutical products, Handwash, Sanitizer, Balm, Inhalers etc. Responsible for investigation of non-compliance with Contract manufacturer. Process Validation and Stability study execution and data review APQR preparation, Witness ma...

Monitoring of Contract manufacturers of Rest of India region (Except North and West India) Quality Oversight at Contract manufacturing sites. Regional representative for Rest of India for overall Quality compliance FG Inspection, Review of batch records and Batch releases Review of Finished product related data to support new Third Party Launch IPQA - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. Monitoring of all shop floor activities covering OSD, Oral Liquid, External and Sterile products. Process Validation and Stability study execution and data review APQR preparation, Witness manufacturing and analysis of finished product. Quality Audits of Contract Manufactur...

Monitoring of Contract manufacturers of North India region Quality Oversight at Contract manufacturing sites. Regional representative for North India for overall Quality compliance FG Inspection, Review of batch records and Batch releases Review of Finished product related data to support new Third Party Launch IPQA - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. Monitoring of all shop floor activities covering OSD, Oral Liquid, External and Sterile products. Process Validation and Stability study execution and data review APQR preparation, Witness manufacturing and analysis of finished product. Quality Audits of Contract Manufacturers & compliance review CMO Manage...

Monitoring of Loan Licence Site located in Navi Mumbai. IPQA/Shop floor activities monitoring - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. (Preferred External preparations and Oral Liquid formulations) Quality Oversight at Loan Licence Sites and tracking for closure of actions. FG Inspection, Review of batch records and Batch releases. Site pre-assessment for regulatory inspections as per GMP requirement. Investigation of any non-compliance in co-ordination with LLU Site and tracking closure of CAPA. Review and COA and analytical data before release of finished product from LLU Site. Review of Finished product related data to support new product Launch. Process V...

Monitoring of Contract manufacturers, Process Validation, Stability Study, Quality Agreement, APQR, FG Inspection and batch release. Responsible of co-ordination with regional representative to harmonize Quality systems across all LLU Sites. Quality Oversight at Contract manufacturing sites on periodic basis. Protocol preparation and execution of process validation for all dosage forms-Pharma. Stability Study and review of Stability Data as per stability interval. APQR preparation, Witness manufacturing and analysis of finished product. Execution of Quality agreements with all Contract manufacturing Sites. FG Inspection, Review of batch records and Batch releases Review of Finished product r...

Roles and Responsibilities Ensure compliance with cGMP guidelines during batch manufacturing, including BMR review and change control processes. Plan and execute production activities according to approved batch plans, ensuring timely delivery of finished products. Conduct process validation, SOP preparation, and day-to-day operations management to maintain quality standards. Collaborate with cross-functional teams for effective communication and issue resolution. Monitor HPLC analysis results to ensure product conformity to specifications. Desired Candidate Profile 2-4 years of experience in pharmaceutical industry (B. Pharma degree required). Strong understanding of batch planning, batch m...

Ensure current versions of all GMP documents are in use. Prepare, revise, and control SOPs . Implement and enforce (GDP). Conduct internal audits, maintain summaries and CAPA tracking Support in process validation, equipment qualification etc Required Candidate profile Ensure all QA activities comply with cGMP, regulatory requirements & internal quality standards for API & Specialty manufacturing. Contact Mr Deep at 9867038868, Email Id: ops@empowerrecruitments.com

Key Responsibilities: 1. Process Flow Development: Design and develop efficient process flows for new assembly lines. Collaborate with cross-functional teams to ensure the process meets production requirements and quality standards. 2. PFMEA (Process Failure Mode and Effects Analysis): Conduct PFMEA for new assembly processes to identify potential failure modes. Develop and implement corrective actions to mitigate identified risks. 3. Technical Documentation (TDS): Prepare comprehensive Technical Data Sheets (TDS) for new assembly lines, detailing process parameters, machine settings, and operational guidelines. Ensure that all documentation is aligned with industry standards and customer re...

Position Title: Assistant Manager Technical Services Department: TSD Location: PAN India Company: D&H Scheron Electrodes Pvt. Ltd. About the Company: D&H Scheron is one of Indias leading manufacturers of welding consumables. Established in 1966, the company is ISO 9001:2015, ISO 14001:2015, and BS OHSAS 18001:2007 certified. We provide a complete range of welding solutions, including consumables, equipment, training, and fabrication. Guided by our core values of Quality, Innovation, and Import Substitution , we are recognized for offering Complete Welding Support Purpose of the Role: The role involves providing technical support and welding solutions to customers by conducting product demons...

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-10 yrs in API Notice Period - Negotiable Location - Mysore ( Nanjangud) Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical Salary- 20% to 30% hike on current ctc Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions ...