8 Dqa Jobs

Role & responsibilities 1. SOP establishment, implementation of system process, note books, work books, protocols for testing and continuous monitoring of Quality Systems in R & D and ADL of Titan Laboratories and Titan Pharma Plus at various locations through SOPs and periodic inspections. 2. Documentation review , approval , Issuance, archival and control of all documents in R&D and ADL of Titan Laboratories and Titan Pharma Plus at various locations . Example Review and approval of MFR against the lab note books , specifications , MOA against analytical method validations , review of analytical method validation protocol and report. Review of ADL results against raw data. Calibration procedures and records of all equipment and instruments . Review of reference standards / working standards/impurities 3. Online review of R&D and ADL activities, daily in-process checks at RND+ADL , line clearances, all system similar to mfg. 4. ADL stability , method validation ,OOS, OOT , in process checks, method verification etc, 5. Review of documents for application of test licenses / manufacturing licenses of Titan Laboratories and Titan Pharma Plus 6. Review of PDR and all documents of R&D and ADL required for submission to regulatory authorities for Dossier registration for Titan Laboratories and Titan Pharma Plus 7. Establishment, implementation and continuous monitoring of Systems in various departments through SOP and periodic inspections 8. Timely escalations of issues impacting the development / testing of product 9. Support to all sites for audit preparations 10. Execution of any tasks assigned by Management from time to time basis Preferred candidate profile Apply formulation background only

Hi, Greetings from Biophore !! We are hiring for QA department - API. Experience: 2-5 Years Job Location : R&D Center, Pashamylaram . Please go thorough the JD . Should aware of SER Report (Structure Elucidation Report ) Should aware of COA Preparation and Review Interested candidates please share your CV's to "recruitments@biophore.com"

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 - 8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Position: Head - Quality Assurance (Formulation R&D) Markets: USA + Other Regulated Products: Formulations Reporting to: CEO Role & responsibilities Responsible for overseeing all aspects of quality management and compliance of Contract Research Organization facilities mainly for regulated markets i:e USA for different types of formulations. This individual ensures that Product Development and research activities adhere to regulatory guidelines, industry standards, and the organization's internal policies. To ensures the organization's research and development activities meet regulatory, ethical, and quality standards. Responsible for establishing, implementing, and maintaining the organization's quality management system (QMS), ensuring it aligns with Good Laboratory Practice (GLP) guidelines and relevant regulatory requirements Lead investigations into quality issues and deviations, ensuring proper CAPA (Corrective and Preventive Actions). Identify, assess, and mitigate risks related to research quality. Serve as the primary liaison for regulatory authorities during inspections. Review and approve QA-related SOPs, policies, and procedures. Reviewing data, reports, and other documentation to ensure accuracy, completeness, and compliance with quality standards. Oversees audit preparation and execution, addressing any findings and implementing corrective actions. Conducting internal audits to assess compliance with SOPs, regulatory requirements, and GLP guidelines, as well as audits and inspections from regulatory bodies. Managing & developing the QA team as well as ensuring that they possess the necessary skills and knowledge to carry out their duties effectively. Responsible for developing and implementing training programs for staff on quality management procedures and regulatory requirements. To critically evaluate and troubleshoot complex problems, making informed decisions that ensure the integrity of the research and compliance with regulations. Preferred candidate profile M.Sc / M.Pharm with 12 to 20 years of experience in Research Quality Assurance / Developmental Quality Assurance in Formulations Pharma / Biotech CRO or R&D Centre. 1220+ years in quality assurance, with at least 5 years in a leadership role. Strong background in GLP environments within a CRO or pharmaceutical R&D setup. Experience in a Quality Assurance, particularly in a Contract Research Organisation / CRO setting, is highly desirable. A deep understanding of GLP & USFDA regulations, and other relevant guidelines is essential. The ability to analyse complex data, identify potential issues, and develop solutions is necessary. Strong auditing and inspection readiness experience. The ability to lead and motivate a team, delegate tasks, and manage resources effectively is crucial. Effective communication, both written and verbal, is required for interacting with internal teams, external stakeholders, and regulatory agencies. Problem-solving and critical thinking. Detail orientation with a strategic mind-set. Recruiter's Contact Details: Dharmesh Sikligar BEST-FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09558802906 Website: www.bestfitrecruitment.co.in

Key Roles & Responsibilities:1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities. 5. Periodic audits of R&D laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data. 6. Effective maintenance of R&D records, distribution and archival systems. 7. Perform cGMP audit of R&D facilities and operations. Assist the team in auditing contract manufacturers/ vendors/ contract testing laboratory. 8. Ensure R&D team is trained for their relevant job function and GMP/ GLP training. 9. Provide quality related inputs to new projects, existing project, up gradations etc. 10. Participate in identification of key starting material (KSM)/ registered starting material (RSM) and ensure that it is correctly identified. 11. Participate in handling of OOS, OOT, Deviations, Batch failures, investigations and CAPA implementation at site. 12. Establish raw material standards by studying manufacturing/ R&D requirements-conferring with suppliers. 13. Responsible to follow the safety and environmental procedures deployed in the site. Responsibilities Qualifications Graduation and above in Science / Pharmacy

Review the Lab validation Protocol and Report of CRD Review of Process Development report for DMF filing. Required Candidate profile Lead the DQA department to implement CGMP rules and regulations in Research & Development.

Dear Respect Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation QA Department Job description -4 -7 Yrs Development Quality Assurance / Formulation Quality Assurance R&D: Handling of QMS documents and Ensure the SOP compliance Review of Formulation Analytical Development Documents & Formulation Product Development Documents. Method Validation and Transfer Protocols and Reports Product development with QbD approach Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs. Review of FRD activities (LNBs,BDRs, PDRs, MFRs and MPR) SOP’s and Guidelines Preparation and Review and Approval of SOP’s. Responsible for conducting Internal Audits/External Audits for Cross functional Departments in Formulation Division and External Division. Conducting and Coordinating Employee Trainings. Responsible for Review and Approval of Vendor Qualification Please Share update resume: careers@biophore.com Ref to Friends or colleagues. Total Exp: Current CTC: Exp CTC : Notice Period: Designation:

Role & responsibilities Review of Analytical method validation, method transfer and method verification protocols & reports. Review of method development reports. Review of Stability & Holding Study analysis data. Review of equipment qualification /calibration/ validation reports (IQ, OQ, PQ) related to all analytical instruments. Should have knowledge on review of Specifications & Standard test procedures. Review of reference standard and impurity COAs and characterization data. Should have knowledge of GTI & Nitrosamines risk assessment. Responsible for issuance and archival of documents. Should have good knowledge of ICH guidelines, USP general chapters. Should have knowledge of QMS activity (Incidents, Change controls). Review of Empower and other analytical instruments audit trails. Responsible for maintaining GLP & GDP at the workplace. Excellent written and verbal communications skills. Preferred candidate profile