Greetings from Jubliant Generics…!!!! We are hiring following positions for our plant located at Roorkee. Post Name: Manager – Mfg Compliance Qualification: M.Pharm/ M.Sc/ B.Pharm Experience: 11 – 15 years of relevant experience in Pharmaceuticals. Exposer to Regulatoru guidlines and faced various regulatory Audits such as US-FDA, MHRA, TGA, ANVISA, PMDA etc. Job Context: To review of Quality notifications like deviations and investigations for proper closure. Review of Non Conformances, deviations, change controls, internal Audits, Annual product quality reviews and to perform assessment on other impacting documents and related activities Challenges: Meet time lines and to be the part of investigation team and lead the investigations of manufacturing section for change control, Non-conformances, deviations, CAPA, Quality risk assessment, OOS,OOT, any other failures; and ensure the effective implementation of CAPAs. KEY ACCOUNTABILITIES:
Handling and guiding production personnel in closure of change controls and deviations.
Follow ups with respective departments for all the above notifications and ensure timely closure as per timelines.
To ensure extension to various quality notifications are complying with requirements.
Shall be responsible to participate in Quality Risk Management exercises whenever required and to facilitate the Quality Risk Management exercise.
Self-inspection of production department and cross functional departments. Review of Self-inspection notifications and ensure timely closure of action suggested.
Assist in internal & external audits related activities.
To perform gap analysis with respect to cGMP guidelines, current regulatory requirements & corporate policies/ SOPs, wherever required and to comply with the requirements and endorse the same.
Ensures proper training is being done to all the personnel regarding the process, SOP’s, Compliance with CAPA.
Ensure the technical writing in line with regulatory guideline.
Ensure the effectiveness of the CAPA
Updating cGMP related practices and recent regulatory up gradation to the personnel working in the shop floor to improve the systems.