Ahlcon Parenterals (India) Limited, a B. Braun group company, located at Bhiwadi, Rajasthan is a major pharmaceutical formulation manufacturer of both Large and Small Volume Parenterals (LVP and SVP) for domestic as well as export markets. We commit to a Zero Defect Quality policy, made possible through the use of technologies and processess that ensure the delivery of high quality products and compliance to Current Good Manufacturing Practices. We also commit to sustainability efforts around our facilities and ensure compliance to global ISO standards.
Key Responsibilities:
- Ensure cGMP compliance at site.
- Responsible for dispensing of RM and PM.
- Responsible for sampling of product.
- Responsible for line Clearance before going to dispensing, manufacturing, filling and packing of Batch.
- Responsible for In-process quality control checks as per BMRs.
- To check environmental & personnel monitoring procedure and results as per SOP.
- Monitoring the facility cleanliness and verification of equipment cleaning records.
- To check & strictly follow line clearance before starting of each operation.
- Responsible to monitoring viable particle count, Non-viable particle count.
- Co-ordination with All Departments for collecting reports.
- Checking of equipment usage logs with respect to Batch records.
- Responsible for follow and implementation of respective SOPs in the production and shop floor.
- Responsible for compilation & review of BMR / BPR and submission in QA for batch release.
Competencies for the Role:
- Good Knowledge of media fill simulation study.
- Good Knowledge of Filling BMR & BPR & Review of Line Documents.
- Having good Knowledge on current Regulatory guidelines, cGMP, & GDP.
- Knowledge of IPQA Activity as Dispensing, Manufacturing, Filling, and packing of Batch.
- Smooth execution of work within timelines and on-time delivery, strong communication with the team.
- Having Good Knowledge of In-process quality control checks as per BMRs.
- Good knowledge Handling of QMS activities like Change Control, Deviation, Incident etc.
- Having Knowledge Operation of Portable Non-Viable Particle Counter.
- Good Knowledge of Aseptic processing in sterile area.
- Having good exposure to working on shop floor activity (IPQA)
Qualification and Experience:
B. Pharma with 2 to 3 Years of Experience
To know more about Ahlcon Parenterals you can visit our website https://www.ahlconindia.com/en.html