Job Description
To oversee all activities performing in accordance to the established SOPs /Protocols /any cGMP document and capture the data in relevant documents as per Good documentation practices.
Raising of incidents and Review of investigation reports.
Perform the temperature trials and review the final values of PID form.
Preparation and review of SOPs.
Preparation and updation / revision of Master formula, Process flow.
Initiation and closing of change control action plans.
Train the shop floor people on Approved documents as mentioned in the change control.
Preparation & Review of PPQ protocol/report & BPR for existing products, where changes are made and validation or process qualification identified.
Ensuring that all the trial recommendations are captured in the validation batch production record and its operational convenience.
Responses to internal & external audits and implementation of audit points in the shop floor.
Preparation & Review of batch production record for reprocess/reworking.
Involve in Site transfer & New products manufacturing process and Necessary documentation.
CAPA management.
Ensuring that the production facilities are clean and maintaining high standards of housekeeping.
To maintaining discipline at the workplace.
To give and share specific instructions received from HOD.
To ensure the entry of batch related activities (Start time, input, output etc.) in SAP.
To train the production personnel on the revised SOPs, Critical Process Parameters, cGMP and Operational safety.
To allot the manpower based on the requirement for process monitoring.
To executive & monitor commercialization of CPP processes.
To work on process modification & cost Reduction implementation.
Preparation & review of documents related computer system & automation. Review of FRS, FDS.
Preparation & Review of PFDs & P&IDs.
Reviewing equipment DCS & MES qualification as per the protocol and operational. Qualification.
Review PHA, PSI, PSR and Safety, Environmental related document and strictly adhere to requirement of SHE.
To undertake any other job as may be assigned by the Site Head.
Upman Placements is a firm of Researcher & Recruitment Specialists. The company started life in 2002 in India as a recruitment specialist firm. The company has built a stellar reputation for high ethical standards, a specialized focus and unparalleled service. Emerged As one of the only truly global specialized staffing firms focusing exclusively in professional positions for our clients spread across more than 20 countries with a sizable presence across industry levels. With footprints in competitive markets of India, Europe, United Kingdom, Middle East, Singapore, Malaysia, Philippines, Indonesia, Brunei and East & Central African countries.
