13 Validation Protocol Jobs

-Check documents like packing sheets, Temp Records, Logger readings -Exp with CAPA documentation -Monitor & maintain the temperature systems -Provide training & prepare training records -Branch visit & perform self inspection activity for branches Required Candidate profile -Male/Female willing to travel (PAN INDIA) -Exp in food/pharma industry preferred -Exp in CAPA documentation is a MUST -Excellent verbal and written communication skills Perks and benefits PF, ESI, Mediclaim, Bonus, PL

Role & responsibilities: The candidate would be required to take on the responsibility of ensuring quality product and production efficiency. Some of the key responsibilities that may be given are: 1. Review and maintain batch records, SOPs and quality documentation. 2. Conduct in-process checks and ensure GMP compliances. 3. Perform internal audits and assist in external audits (FDA, WHO, ISO, etc.) 4. Handle deviations, CAPA, change controls, and OOS investigations. 5. Ensure data integrity and documentation as per regulatory requirements. 6. Coordinate with QA, QC and Production teams to maintain quality standards. 7. Carry out validations and risk assessments Preferred candidate profile: The candidate should be hardworking and honest. Should be able to manage time, prioritize work accordingly and work well within a team. Proficiency in MS Word/excel and English is mandatory. Experience in testing is desirable but Freshers may apply

JD Collaborate with cross-functional teams on equipment qualifications and IQS. Ensure IT compliance through validation processes. Develop computer system validation plans and protocols. QMS candidate shud b frm pharma industry gud communic skills. Cafeteria Office cab/shuttle Accessible workspace Health insurance Provident fund Annual bonus

Roles and Responsibilities Ensure compliance with quality management systems (QMS) through implementation, maintenance, and continuous improvement of ISO documentation. Prepare SOPs for various processes such as BMR, CAPA, Change Control, Cleaning Validation, etc. Conduct qualification testing and validation protocol execution to ensure product quality and regulatory requirements. Develop and maintain accurate records of test results, reports, and certificates related to quality assurance activities. Collaborate with cross-functional teams to identify areas for improvement in quality control processes. Desired Candidate Profile 5-10 years of experience in pharmaceutical industry with expertise in QMS implementation. Strong understanding of GMP regulations and industry standards like ISO 9001:2015. Proficiency in preparing documents like BMR, SOPs, Capas, Change Control procedures. Experience with cleaning validation process validation protocol execution.

We are seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines. Key Responsibilities: Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control. Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution. Review and approve Master Production Records, Batch Production Records, and Validation Protocols across departments. Coordinate process, cleaning, and analytical method validations as per the Validation Master Plan. Prepare, review, and manage regulatory documentation including DMFs/ASMFs in CTD format (Modules 1, 2, 3). Liaise with regulatory authorities and customers for audit readiness, document submissions, and compliance queries. Oversee training programs for plant personnel and ensure continuous adherence to GMP standards. Conduct Product Quality Reviews and implement risk management tools like FMEA, HACCP, and HAZOP where applicable. General Requirements: Thorough understanding of global regulatory guidelines (ICH, WHO, USFDA, etc.). Strong analytical, documentation, and decision-making skills. Proficient in regulatory submissions and quality review documentation. Familiarity with stability studies and establishing expiry/retest periods. Hands-on experience with validation protocols and equipment calibration systems. Ability to lead cross-functional teams and ensure site-wide compliance. Excellent verbal and written communication skills. Willingness to take ownership and drive continuous improvement initiatives.

Review and approve validation protocols (IQ/OQ/PQ), reports, and related documentation for manufacturing equipment, utilities, and processes. Provide QA oversight during the planning and execution of process validation and cleaning validation activities. Ensure all validation activities are conducted in accordance with current Good Manufacturing Practices (cGMPs), company policies, and industry standards. Participate in risk assessments (e.g., FMEA) to support validation strategy development. Support investigations and change controls related to validated systems or processes. Collaborate with Manufacturing, Engineering, QC, and Regulatory Affairs to ensure validation deliverables are aligned with product quality requirements. Maintain validation documentation and ensure data integrity in all QA records. Conduct QA review and approval of protocols and reports for re-validation and periodic reviews. Support internal and external audits and inspections, providing SME support for validation topics.

We are specifically opening this position to people in an Assistant Manager or Team Leader Role who think they are ready for the Next Challenge! The person filling this role should be meticulous and experienced to lead method development, validation, stability studies, and technology transfer activities at Synnat Pharma , Visakhapatnam. This role involves close collaboration with R&D, QC, and Regulatory teams, supporting product development and compliance with global pharmaceutical standards. The ideal candidate will have strong analytical expertise, leadership skills, and a commitment to regulatory compliance and continuous improvement. Responsibilities: Develop, optimize, and validate analytical methods (HPLC, GC, UV-Vis, Dissolution) as per ICH and regulatory guidelines Prepare and maintain validation protocols, analytical reports, and ensure GDP compliance Oversee method transfer to QC, provide training, and address troubleshooting Conduct stability studies and prepare data reports in alignment with regulatory expectations Collaborate with cross-functional teams (QA, QC, Packaging, Regulatory) to support product development Investigate and resolve analytical issues including OOS, OOT, and deviations; implement CAPAs Maintain up-to-date documentation and ensure compliance with GMP/GLP standards Evaluate vendors and key starting materials (KSMs); provide insights to management General Expectations and Past Experience: Strong understanding of analytical chemistry principles, techniques (HPLC, GC, Dissolution, UV-Vis) Proven experience in method development, validation, and regulatory compliance Familiarity with global pharmaceutical regulations (FDA, EMA, WHO) and ICH guidelines Hands-on experience with pharmaceutical quality systems (GMP, GLP) Skilled in handling regulatory submissions and documentation Excellent problem-solving abilities using data-driven approaches Leadership skills with experience in mentoring R&D scientists Familiarity with CAPA systems and good documentation practices

1. Preparation of Annual/Periodic Product Quality Review (APQR/PQR) 2. Preparation of finished product specification (Tablet, External preparations & Injection) 3. Preparation of Protocol and Reports of PROCESS VALIDATION Batches. 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory department. 6. Working Hands on MARKET COMPLAINTS and CAPA. 7. Preparation of Master Formula Record (MFR) and Preparation Of (SOPs). 8. Preparation of EQUIPMENT QUALIFICATION documents i.e. IQ, OQ, PQ protocol and Reports during Installation of New Instruments/ Equipments. 9. Identification of Hazard and Calculation of Risk associated with product or daily activity. 10 Participation and Handling of SELF INSPECTION Reports (INTERNAL AUDIT). 11. Preparation of Audit & Maintenance of Post Audit Documents (compliance reports). Desired Candidate Profile Bachelor's degree in Science (B.Sc) or Pharmacy (B.Pharma). Male candidate will be preferred.

Key Responsibilities:** - Conduct thorough testing and validation of [products/processes, e.g., software applications, pharmaceutical formulations, or manufacturing processes] to ensure compliance with quality standards. - Develop and execute QA test plans, protocols, and reports. - Identify, document, and track defects, ensuring timely resolution. - Collaborate with cross-functional teams to maintain quality throughout the product lifecycle. - Ensure adherence to regulatory standards (e.g., ISO, GMP, or other relevant certifications). - Contribute to process improvements and quality assurance strategies. **Skills Required:** - Strong knowledge of QA methodologies, tools, and processes. - Familiarity with [specific tools/software, e.g., Selenium, JIRA, or GMP protocols]. - Analytical mindset with attention to detail. - Excellent communication and teamwork skills.

Role & responsibilities protocol Preparation, review and execution for plant qualification preparation of process validation protocol, preparation and compilation of validation report co-ordinate for 3rd party calibration risk assessment preparation annual product review QMS, Change control, DEviation Preferred candidate profile B.Pharma/M.Sc with minimum 6-8 yrs experience in QA. candidate must have exposure of working in regulatory pharma plant.

Lead end-to-end product development projects in alignment with customer requirements and company objectives CAD tools used; manage BOM, DVP, and APQP documentation Drive prototype development, testing, and validation activities for new products Required Candidate profile Strong understanding of APQP, PPAP, FMEA, GD&T Must Have Experience in Sheet Metal Industry Experience with Tier 1 & 2 automotive suppliers is highly preferred Proficient in SolidWorks, AutoCAD

Responsibilities: * Ensure compliance with regulatory requirements through quality control measures * Conduct process validations, cleaning verifications & change controls * Prepare validation protocols & reports

Greetings from Kashiv Biosciences!!!! We are looking for Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities: Responsible for Engineering compliance , Validation and QMS activity. , Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions. Representing as a Subject Matter Export of Engineering department in front of regulatory auditors. Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness. Responsible for technical agreements with vendors who have work at Plant premises. Responsible for preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled. Responsible for change control/deviation management/CAPA Through Track wise management System. Facing the Regulatory, Customer, Internal Audits and preparation of compliance. SOPs and Protocols Training for the new personnel and refreshment training for existing team members. Co-ordination with CFT line Production, QC & QA department to execute any engineering documentation related works. Candidate Details The candidate should be from Pharma industry only having exposure to Parenteral/ Injectables. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to equipment qualification, Validation and QMS . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences