Officer

3 weeks ago


Baddi, India Abbott Laboratories Full time

Followings will be the responsibilities of the position holder:

- To prepare protocol/report for process validation, cleaning validation and hold time of products. Review, compilation and maintain the process and cleaning validation reports & batch records.
- Compliance of cGMP in the oral dosage form & to follow GDP with Data Integrity compliance.
- Manufacturing and Packing process compliance in accordance with approved BMR/BPR.
- Coordination with R&D and site CFT in case of New Product Internalization. To assist investigation activities.
- SOP training in ISO train of self-train within stipulated time.
- To facilitate the release of finished goods product by timely compilation of Reports.
- Preparation and review of Qualification and Validation documents (URS, DQ, IQ, OQ, PQ etc.) for ODF facility.
- Execution of qualification and requalification activities for OSD facility.
- Co-ordination with other departments for streamlining qualification activities for OSD facility.
- Preparation of SOP, training modules on validation and execution of training sessions for OSD facility.
- Support the evaluation of change control to establish validation assessments and requirements during process and equipment modification.
- Prepare the assessments to support that validated critical process and operational parameters are within qualified parameters.
- To ensure compliance of validation/qualification activities as per Regulatory requirements.


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