Date PostedJanuary 29, 2023
Location (State / UT)
Experience12 Years, 15 Years
Desired QualificationBachelor Degree, Master’s Degree
Roles and Responsibilities:
- Coordinate and conduct quality audits of the pharmaceutical manufacturers (Finished Dosage Form, API/PPM/KSM, etc.) as per schedule for the Europe region.
- To analyze the risk associated with the audit findings.
- To evaluate and correlate the audit findings against relevant regulatory guidance documents.
- To prepare the audit reports and follow up for a response.
- Review of response provided by the vendor and initiate the closure of the audit.
- The role includes extensive traveling across Europe and other countries.
Essential Job Functions:
- Coordination and execution of GMP system audits (Facility &Equipment /Material system/ Production system/Packaging & Labelling control/Laboratory control/Quality management system) of Vendors for EU region.
- Audit of CMO sites of EU region.
- Audit of CNF/Warehouses and affiliates.
- Audit of sites as internal audits.
- Review of compliance report and evidence for closure of audit observations.
- To provide review comments, in case of further clarity/evidence is required to close of audit observations.
- Maintain tracking for audit compliance reports and ensure closure.
- To observe the provision of the Behavior Code, of the Collective Labor Agreement, of the Internal Rules, the Norms of Labor Security and Health (SSM) and of the Emergency Situations (SU), the legislation in force, orders, internal decisions;
- To participates in periodical training in Labor Security and Health and Emergency Situations;
- To obey the hierarchical discipline, He observes the correct circulation of the information inside and outside of the department, He keeps the confidentiality of all data and documentation as of the internal data of the company;
- Responds to the fulfillment of the mentioned duties, at the provided quality parameters and terms established by the Companys Management;
- Responds to the knowledge and observance of the legal provisions, in carrying out the work duties;
- The present duties do not have a limitation character. He also carries out other duties received from her superior and related to the department or with the activity that leads to the good functioning of the department or of the company;
- To responds administratively, materially, and civilly for practicing, with good faith, the present job description.
Requirements and Qualifications:
- MSc / B. Pharma
Industrial Experience & Knowledge:
- Experience: 12 – 15 Years in the field of Quality Assurance / Production specifically APIs. Additionally, knowledge related to formulations can be added advantage.
- Having knowledge of regulatory guidances specifically MHRA, EDQM EMA, etc.
- Computer profiecient. (Word, Excel, Powerpoint, etc)
- Must have good communication skills.