Executive recruitment company Monroe Consulting Group's Industrial Division is exclusively partnered with multinational organization who is well established in the field of manufacturing.
The ideal candidate will be responsible in supporting the drug product line (filling and formulation).
- To ensure the manufacturing processes and critical parameters of the processes of the sterile products are performed as per the respective approved procedure and harmonization of procedure in the facility.
- Handling of Deviations, Change control, SOP, OOS, OOT and all other cGMP records.
- Tracking of Deviations, Change control, CAPA, OOS and OOT to avoid the overdue and timely closure of the same.
- Review of Standard Operating Procedures (SOP) for all the activities of the department pertaining to area, Personnel and machine in coordination with Quality Assurance Department.
- Ensure timely completion of qualification by inter departmental coordination in case of introduction of any new equipment, instruments and system to facility.
- Qualification of the new facility, filing line, equipment, area, utilities and aseptic process simulation
- Ensure timely completion of validation / Qualification protocol and reports to support production.
- Review and ensure the hygiene of the validation planner and aseptic process simulation planner.
- Ensure timely completion of MFR and BMR as per the scheduled timeline.
- Ensure the audit readiness and compliance adherence.
- Ensure the timely completion of the cleaning validation and process validation package as per the requirement.
- Ensure timely completion of the proposed CAPA for external as well as internal audit observation compliance
- Look into all potential hazardous conditions, investigate all hazardous occurrences and accidents in the work area and suggest corrective and preventive measures.
- Identification of the continuous improvement project and preparation of the project charter for the implementation.
- To identify the gap as per the current regulatory expectations and support the department for implementation
- Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Biology, Chemistry, Science & Technology, BioTechnology, Engineering (Bioengineering/Biomedical) or equivalent.
- Required skill(s): Fill Finish, Aseptic Environment, Grade A cleanroom.
- At least 12 year(s) of working experience in the related field is required for this position.
- Preferably Senior Executives specializing in Engineering - Chemical or equivalent.