Website Panacea Biotec Ltd
Post Name: Scientific Officer
Department: Filling & Solution Preperation
Experience range (Years): 0-N.A
Job Responsibilities:
SUMMARY:
1. Execution and preparation for IRM Dispensing and solution preparation activity for Formulation of vaccines as per production planning.
2. To prepare SOP’s, validation protocols, extended documents/reports Preventive maintenance schedule, log books, calibration schedules and regulatory guidelines.
3. Ensure:
· Timely availability of resources and infrastructure.
· Equipment and facility are to be maintained in optimal operational conditions.
· On Time in Full (OTIF).
· Regulatory Compliance
· Successful adherence to GMP, GDP of the Plant compliance.
· Provide a culture of continuous improvement in Production.
o Create cohesive and peak performance for Production team
o Consolidates inputs from all subordinates & peers to ensure that all sub functional views are represented.
o Responsible for the implementation of company’s policies.
RESPONSIBILITIES :
Primary Job responsibilities:
Technical
o Responsible for preparation of SOP’s, validation protocols, extended documents/reports Preventive maintenance schedule, log books, calibration schedules and regulatory guidelines.
o Responsible for planning and execution of qualification activity of respective area equipment such as (IQ/OQ/PQ) and process related qualification.
o To ensure the cleaning, Operation, documentation & maintenance of solution preparation area as per production planning.
o To ensure GMP compliance as per the applicable National and International rules and guidelines Such as Schedule M and World Health Organization (WHO).
o Responsible to ensure the online documentation as cGMP along with routine log book management of production activity & equipment.
o To ensure reediness of overall IRM Dispensing and solution preparation area operation.
o To execute the media fill activity as per schedule.
o Active participation in the execution of the R&D and trial batches.
o SAP entry of batch related information
o To prepare the DIM associated to the Software or GXP equipment’s
Regulatory
o To ensure GMP compliance as per the applicable National and International rules and guidelines Such as Schedule M and World Health Organization (WHO).
o To prepare for successful audit, inspections and visits by parties and drug authorities of the company’s production activities.
o Ensuring that Employees follow ALCOA+ principals, Good Documentation Practices, and do not breach the Data Integrity requirements as defined by the company and regulators.
Communication
o To discuss day to day Plan with HOD and all concern departments.
o Planning and coordinate with warehouse for material issuances.
o Coordination with QC for QC related activity (Sampling/Testing/Release/EMP).
o Coordination with QA for daily operation/ QMS/Documentation/Validation.
o Coordination with Engineering for daily operation related activity.
