Intas Released Job Openings On 04/07/2022.Intas Experience spanning three decades in healthcare, with a wide range of formulations to meet the needs of ailing humanity, Intas Pharmaceuticals headquartered at Ahmedabad (India), is now a force to reckon with, in the global pharma horizon. With expertise in a range of formulations, from tablets to injectables to newer drug delivery systems, Intas is currently ranked 17th among the Indian Pharma majors..Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Intas Recruitment 2021 are provided below. Interested and eligible candidates can submit application along with resume.
Intas Recruiting M.Pharma candidates with 00 -02 Years Experience for Quality Assurance Position.Complete Details for the Quality Assurance as follows.
Important Details :
- Location :Ahmedabad
- No of Vacancies: NA
- Details of Salary: 3,75,000 – 6,50,000 P.A.
- Opening date for online Application: 04/07/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Related Job: Aurobindo pharma Walk In Interview On 5th July 2022
Job Description/Skills Required
- Supports the Clinical Quality Management System to ensure the compliance as per regulatory and company Ethical and Good Clinical Practice requirements. Also, Patient safety and data integrity are respected.
1. Direct PMQA Responsibility
- Review of CRO monitoring report of late phase studies in compliance with regulatory requirement and as per approved clinical study protocol for all assigned projects.
- Work with CRO colleagues, to implement, review and maintain tracking of incidents within the trials, advising on CAPAs to be implemented and ensure completion in a timely manner for assigned studies
- Assist to team for Management of clinical trial in terms of project hygiene for assigned projects
- Assist to team for IMP Management for assigned projects
- Responsible for management of all Project & service contract of all clinical studies
- Ensure that Standard Operating Procedures (SOPs) are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate.
- Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- QMS activities which includes management of Change control, CAPA, Deviation & issuance of forms
- Preparation of Sponsor clinical study file as per ICH-GCP E6 requirement for assigned projects
- Determine staff SOP training requirements relating their role and maintain oversight of training to ensure all staff members are trained on each SOP as required. This will involve close working with other senior trial staff as needed.
- Archival related activities for all studies & system documents as per standard operating procedures.
- Coordination with respective stake holder for smooth functioning
2. 1stYr. Learning & Assist to PMQA Team on;
- Review of clinical trial related documents (Protocol, Electronic CRF, ICF, Study Plans & Reports etc.)
- Establish an internal risk-based audit plan and perform for Vendor/ CRO Qualification for clinical studies and ensure the compliance as per standard operating procedures and guideline requirement
- Establish an internal risk-based audit plan and perform clinical study site audits and ensure that trial are conducted as per regulatory requirement and approved clinical study protocol. Also guide on corrective and preventive actions (CAPA) to address any non-compliance with procedures and/or clinical trial regulations
- Performing monitoring of Phase 1 clinical study
- Literature search for developing study protocol
- Quality review of Pharmacovigilance Document (i.e. PSUR, RMP & SDEA)
- Handling of post marketing complaint of biotech products
- Product market complaint with respective client & vendor
- Preparation, timely updation and management of all SDEA for all clients