Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Senior Executive - MDM Strides Pharma Science

4.0 - 7.0 years

5 - 8 Lacs

bengaluru

Work from Office

Creation and Review of Master documents: Specification, standard testing procedure, analysis and general procedure, raw materials and finished products in LIMS. Initiation and tracking of QMS events and evaluation of impact on Master documents Revision of Master documents: SPEC, STPs and general procedure based on the approved change control. Ensuring RFT in documents by creating error free documents. Implementation of Pharmacopeial changes and source change document. Review and tracking of DMF in PLM and preparation of Master documents based on AMV/AMT/Evaluation report. Handling of LIMS master data activities and resolving of SAP/LIMS related queries. Creation and revision of Raw Data Sheet. Preparation of Residual solvents justification reports. Harmonization of SPEC/STP/RDS for API and Excipients. Maintaining track wise discipline by tracking pending tasks, closure of quality events. Ensuring compliance / completeness for applicable Logbook/Register. Creation of harmonized templates for Spec/STP/RDS. Tracking of CAPA assigned and checking on the task applicability to Master data team based on RCI. Implementation of previous learning / improvement points to the upcoming projects /during subsequent revision of Spec/STP/RDS. Co-ordination and conducting internal trainings and learning sessions for entire Master Data Team.

Posted 12 hours ago

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Senior Manager, Manufacturing Injectables Amneal Pharmaceuticals

12.0 - 16.0 years

0 Lacs

ahmedabad, gujarat

On-site

The role involves ensuring CGMP compliance and supervising overall production activities of the manufacturing area of multiple assigned manufacturing lines. Additionally, the position requires reviewing and maintaining online documents. You will be responsible for the preparation, review, revision, control, and implementation of standard operating procedures. You will also handle the preparation and review of master production documents, protocols, reports, and various document management tasks such as BMRs and BPRs. Your duties will include managing Change Control, Deviations, CAPA, Investigations, and ensuring line clearance activities are conducted before operations like manufacturing, filling, capping, and packing. Generating general purchase indents, preparing production planning, and daily production reports based on achieved goals will be part of your responsibilities. It is crucial to ensure that all equipment and lines are in validated and calibrated status and to uphold cGMP, GDP, and discipline standards within the department. Additionally, you will be responsible for providing training to subordinates, technicians, and operators, and following any additional activities as required by the Head of Department. Attending training sessions as per the schedule and ensuring compliance will be important aspects of the role. To qualify for this position, you must have a Bachelor's Degree in B. Pharm, with a Master's Degree in M. Pharm or M. Sc. being preferred. A minimum of 12 years of experience in the field is required. Your specialized knowledge, skills, and licenses will further enhance your ability to succeed in this role.,

Posted 3 days ago

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