Endo Pharmaceuticals is a global specialty healthcare company focused on the development and commercialization of innovative therapeutic solutions for patients with unmet medical needs.
Not specified
INR 3.0 - 6.0 Lacs P.A.
Work from Office
Full Time
Job Description Summary Asst. Manager- Statutory Compliance Tool reviewer should understand the compliance tool operations and to provide due support to tool users across organization, to assist in Regular Internal review of compliances submission and approval accorded by various departments and to prepare deviation report for discussion with concerned department and top management. Monitoring of license module of tool with review, updates and monitoring of its conditions. Comparison of existing laws uploaded in the tool with verbatim of law and submit deviation report for rectification. Job Description Understanding Compliance Tool Operations: Oversee and assist with the Statutory Compliance tool, including compliance changes, scheduling, updates, event assessment, and MIS generation. Ensure timely submissions, review and draft reports, and provide training to PAR India employees. Prepare weekly/monthly MIS and manage updates in the compliance tool. Assisting in Regular Internal review of compliances submission and approval accorded by various departments Understand the business, assist in audit scheduling, and prepare document request lists. Circulate requests, organize meetings, complete reviews, and draft compliance reports. Follow up on non-compliance, maintain a compliance database, and track review outcomes Assisting in Comparison of Tool Vs Existing laws: Identification of applicable statues for the company and comparison with the tool for identification of gaps. Comparison of checklist uploaded in EY with the Act and Rules identified to identify gaps, mistakes/changes to be made in the tool in line with current law. Assisting in writing mail to EY to sort out the differences noted. Assistance in according Monitoring of Licenses in compliance tool: Reconciliation of license as per tool and physical held across locations. Conditions mentioned in the licenses Vs up-dation done in compliance tool. Education Experience The concerned person should have qualification CS-Inter with/Bachelor of Law with 2 to 3 years of experience handling Compliance audit or Compliance tool Development. Skills Abilities Should have worked on compliance tool earlier or Big 4 experience or leading audit firms within 100 doing similar activities. Compliance audit/ISO audit with report writing skills and If worked on EY compliance tool will be added advantage. Good Communication skills.
Not specified
INR 3.0 - 7.0 Lacs P.A.
Work from Office
Full Time
Job Description Summary Responsible for Analytical data review of Stability, Finish Product, Investigations (OOS/OOT/Deviations) . Handling of Technical agreement, QMS Trending, Self inspections. Job Description Knowledge about ICH, USFDA guidelines Data integrity principles. Knowledge on review of Qualification calibration of Analytical instruments. Technical knowledge on data review for finished product/stability/Raw material samples and analytical method validation/verification Having knowledge of quality management system (Change control, CAPA, Incidents, OOS, OOT) Experience to handle the internal external audits. Preparation and Review of SOP, laboratory documents like method validation/ verification protocols reports, SOP s, Standard Test Procedure Specification. Maintain good documentation practices. Participate in Investigation of incident, deviation, OOS, and OOT during analysis. Education Experience M.Sc. Chemistry/M. Pharm with 6-7 years of related experience.
Not specified
INR 40.0 - 45.0 Lacs P.A.
Work from Office
Full Time
Job Description Summary This role is deft in development of formulation, scale up and demonstrates the scientific capability and accessibility to current portfolio and pipeline products. The incumbent will also be jointly responsible for achieving targeted formulation development by providing necessary scientific support to team members. The incumbent is also responsible for literature search, formulation trails, scale documentation for complex injectable products, including solution, suspension, emulsions and lipid based products. Job Description Prepares a developmental plan specifying timelines and target completion dates along HOD/ designee. Allocates monitors projects for formulation development to team member as decided by HOD/ designee. Compiles/reviews the formulation development strategy. Guides supports all activities for formulation development for Generic complex injectable products, including solution, suspension, emulsions Lipid based products. Reviews developmental data and having a check during the course of development. Ensures all lab activities follow GLP/GMP. Helps internal/external audit preparation. Monitor qualification activities of instruments/equipment installed at RD Center. Observes laid down standard operating procedure (SOP) as applicable at the all Par Formulation sites (labs, production facilities etc.), including laboratory safety. Supports, reviews, comments and defines way forward after/during literature search on APIs, patents, excipients, and technologies for the development of products. Initiates QMS documentation. Performs monitors formulation technology transfer from PD lab to respective manufacturing unit/ pilot plant with required documentation.
Not specified
INR 3.0 - 7.0 Lacs P.A.
Work from Office
Full Time
FIND ON MAP
Gallery
Reviews
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
Chrome Extension