As the Head of Quality Assurance and Compliance at our Biopharmaceutical company, your role will be crucial in maintaining the highest standards of quality, compliance, and regulatory adherence. Reporting directly to the executive leadership team, you will play a critical role in upholding and enhancing our reputation for excellence in the industry. **Role Overview:** You will be responsible for establishing and maintaining robust Quality Systems to support cGMP activities, ensuring compliance with regulatory requirements and industry standards. Your role will involve managing the Quality Control and Quality Assurance departments, overseeing document control and training systems, and leading quality operations activities for product disposition. **Key Responsibilities:** - Develop and maintain Quality Systems to support cGMP activities - Direct and oversee Quality Control and Quality Assurance departments - Provide oversight of document control and training systems management - Demonstrate expertise in cGMP, Quality Systems, and regulatory guidance - Lead Quality Operations activities for product disposition - Supervise QA and QC Managers - Prepare for and manage regulatory agency inspections - Recruit, develop, and retain quality personnel - Establish a culture of compliance and continuous improvement - Drive continuous improvement initiatives - Lead cross-functional teams to resolve quality issues - Collaborate with Vendor Management for vendor quality requirements - Provide formal and informal performance feedback to direct and indirect reports - Ensure compliance with all company policies and standards - Plan and direct resources and activities of quality and compliance functions globally - Lead Quality responses for information requests and business development proposals - Ensure technical liaison and training activities related to quality and compliance - Maintain knowledge of FDA, EU, MHRA, & EMA regulations and standards - Maintain robust CAPA, nonconformance, and complaint management systems - Travel up to 10%, including international travel, and perform other duties as assigned **Qualifications Required:** - Bachelor's degree in pharmacy, biology, chemistry, or a related field; advanced degree preferred - Certification in quality management preferred - 15+ years of experience in quality assurance leadership roles within the biopharmaceutical industry - In-depth knowledge of biopharmaceutical manufacturing processes - Strong understanding of regulatory requirements governing biopharmaceutical manufacturing - Excellent leadership, communication, and interpersonal skills - Demonstrated experience in leading and managing teams - Highly organized, detail-oriented, and analytical Apply now and join us in maintaining the highest standards of quality, compliance, and regulatory adherence in the biopharmaceutical industry!,
Description: Lead/support emerging markets (and Japan, Canada, ANZ) filing for Biosimilars, NCEs &ANDAs, Query responses, audit support, and lifecycle management. Regulatory support for the filing of IND/CTA to various regulatory agencies. Maintenance of IND/CTA through submission of protocol amendments, addition of investigators, EC approvals, SAE report submission, quarterly/annual Report, etc. Interested Candidates Please share the resumes at [email protected] Requirements: Education: Masters in biotechnology /Pharma- Regulatory Affairs/Pharmaceutical Biotechnology Experience: 12-15 Years Skills: Exposure in Emerging markets, Regulated Markets, Regulatory guidance, Dossier Preparation, Biosimilars and NCEs
As a Regulatory Affairs Specialist at Kashiv India, your role will involve leading or supporting filing activities for Biosimilars, NCEs, and ANDAs in emerging markets such as Japan, Canada, ANZ. Your responsibilities will include: - Handling query responses, providing audit support, and assisting in lifecycle management of the products. - Providing regulatory support for the filing of IND/CTA to various regulatory agencies. - Ensuring the maintenance of IND/CTA by submitting protocol amendments, adding investigators, obtaining EC approvals, submitting SAE reports, and preparing quarterly/annual reports. To qualify for this position, you should meet the following criteria: - Education: Masters in biotechnology, Pharma-Regulatory Affairs, or Pharmaceutical Biotechnology. - Experience: 12-15 years in the pharmaceutical industry. - Skills: Exposure to emerging markets and regulated markets, familiarity with regulatory guidance, experience in dossier preparation, and expertise in Biosimilars and NCEs. If you are passionate about regulatory affairs and have the required qualifications and skills, we encourage you to share your resume with us at manan.hathi@kashivindia.com. Join us at Kashiv India, where we are dedicated to making a difference in the pharmaceutical industry.,
Description: Greetings from Kashiv Biosciences !!! We are looking for a technically strong R&D professional with hands-on experience in Downstream cell culture processes who is interested in transitioning into Intellectual Property (IP) work. This role will provide full training and mentorship in patent analytics while utilizing the candidates scientific expertise to support biosimilar IP strategy, freedom-to-operate (FTO) assessments, and patent filings . The role is Based out of Ahmedabad Key Responsibilities: Apply technical knowledge to analyze patents, scientific literature, and regulatory filings relevant to biosimilar Downstream processes . Conduct patent landscape studies, prior art searches, and FTO assessments with guidance from senior IP professionals . Support the preparation of patentability evaluations, infringement analyses, and invalidity assessments for Downstream manufacturing technologies . Liaise with R&D teams to gather technical data and insights for IP filings and risk assessments. Prepare technical summaries and documentation for patent attorneys and cross-functional teams. Track competitor filings and monitor emerging trends in Downstream biosimilars manufacturing. Assist in drafting technical portions of patent applications, invention disclosures, and IP documentation . Receive ongoing training in patent law, IP processes, and biosimilar regulatory frameworks to build long-term IP expertise. Interested Candidates, please share the resume at my mail id [email protected] Requirements: Candidate details: Education: Master's in biotechnology, Biochemistry, Microbiology, or related field . Experience: 4 -8 years of hands-on industry experience in Downstream process development for biologics or biosimilars ( AKTA Process, Protein Purifications, process scale-up, etc .). Strong interest in developing a career in Intellectual Property and patent analytics . Exposure to regulatory aspects of biosimilar development will be an advantage. Excellent analytical, problem-solving, and scientific writing skills. Good communication skills with the ability to collaborate across multidisciplinary teams. Prior exposure to IP ( patent searches, literature reviews, regulatory filings etc. ) Familiarity with patent databases (e.g., Derwent, Orbit, Patsnap, Google Patents ) Certification or coursework in IP or patent law will be an added advantage.
Description: Greetings from Kashiv Biosciences!!! We are looking for Upstream Production Specialist for our Biosimilar manufacturing facility based out of Ahmedabad . Following are the Roles and Responsibilities. Roles & Responsibilities Responsible for Upstream Production for Mammalian Cell culture . Should have exposure on various Perfusion techniques and Single use Bio reactors . Qualification and validation of equipment. Exposure to Fermentation Process is must. Interested candidates Please share the resumes at manan.hathi@Kashivindia.com Requirements: The candidate should be Lifescience Graduate or Postgraduate. The candidate should have worked in Biosimilars Upstream production (Mammalian Culture) for at least 10 Years and exposure to Perfusion technology is must. The candidate should have worked on Single use bioreactors . Exposure to Regulatory Audit is Must. Should be aware of QMS Documentation. The candidate should have good communication skills.
Description: Greetings from Kashiv Biosciences!!! We are looking for Process Equipment Engineer for our Biosimilar Manufacturing Plant Based out of Ahmedabad . Below are the further details. Roles & Responsibilities Responsible for the Plant Maintenance activity of DS (Drug Substance) section equipment's such as Fermenters, Process vessels, CIP vessels, batch centrifuges, TFF systems, Merck chromatography columns, Filter press . Responsible for Maintaining of biologics MFG units (Cell Culture), Filling Facility (DP),QC,WH and R&D facility . Maintenance of Biologics manufacturing facility (Mammalian) including Development and QC lab(Microbiology). Responsible for QMS Documentation, validation and new Equipment Qualification . Required Instruments Exposure: Bioreactor Fermenter Media, Buffer & CIP vessel Continuous Centrifuge Continues Kill system Homogenizer Chrome system TFF system Autoclave Chromatography Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Requirements: Candidate Details: Experience 08- 12 Years of Process Equipment Maintenance in Drug Substance Facility Education: B.E/ B. Tech(Mechanical/ Electrical/ Electronics/ Instrumentation) The candidate should be from Biopharma industry having exposure Drug Substance and Drug product Maintenance. The candidate should have exposure to regulatory Audits. The candidate should be aware of GDP/ GMP Process . The candidate should have exposure to new equipment qualification & QMS as well . The candidate should have good communication skills.
Description: Greetings from Kashiv Biosciences !!! We are looking for a technically strong R&D professional with hands-on experience in Downstream cell culture processes who is interested in transitioning into Intellectual Property (IP) work. This role will provide full training and mentorship in patent analytics while utilizing the candidates scientific expertise to support biosimilar IP strategy, freedom-to-operate (FTO) assessments, and patent filings . The role is Based out of Ahmedabad Key Responsibilities: Apply technical knowledge to analyze patents, scientific literature, and regulatory filings relevant to biosimilar Downstream processes . Conduct patent landscape studies, prior art searches, and FTO assessments with guidance from senior IP professionals . Support the preparation of patentability evaluations, infringement analyses, and invalidity assessments for Downstream manufacturing technologies . Liaise with R&D teams to gather technical data and insights for IP filings and risk assessments. Prepare technical summaries and documentation for patent attorneys and cross-functional teams. Track competitor filings and monitor emerging trends in Downstream biosimilars manufacturing. Assist in drafting technical portions of patent applications, invention disclosures, and IP documentation . Receive ongoing training in patent law, IP processes, and biosimilar regulatory frameworks to build long-term IP expertise. Interested Candidates, please share the resume at my mail id manan.hathi@kashivindia.com Requirements: Candidate details: Education: Master's in biotechnology, Biochemistry, Microbiology, or related field . Experience: 4 -8 years of hands-on industry experience in Downstream process development for biologics or biosimilars ( AKTA Process, Protein Purifications, process scale-up, etc .). Strong interest in developing a career in Intellectual Property and patent analytics . Exposure to regulatory aspects of biosimilar development will be an advantage. Excellent analytical, problem-solving, and scientific writing skills. Good communication skills with the ability to collaborate across multidisciplinary teams. Prior exposure to IP ( patent searches, literature reviews, regulatory filings etc. ) Familiarity with patent databases (e.g., Derwent, Orbit, Patsnap, Google Patents ) Certification or coursework in IP or patent law will be an added advantage.
Description: Greetings from Kashiv Biosciences!!!! We are looking for Qualification, 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, Equipment Qualification, 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 Quality 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. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Requirements: Candidate Details The candidate should be from Pharma industry only having exposure to Drug Substance(Biosimilars)/ Parenteral/ Injectables. The Candidate Must have B.Tech/ B.E degree and should be working in Engineering Team. The candidate should have minimum 5 Years of experience in handling technical documents. 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.