Sr Executive Asst Manager
Sr Executive Asst Manager
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Job Description
Job Description
The Executive in the Biologics Production Department will play a crucial role in the manufacturing and production of biologic in Promea. They will be responsible for ensuring the efficient and compliant production of biologics adhering to quality standards safety regulations and production schedules.
Key Responsibilities
Batch planning and of batch.
Dispatching the (DRUG SUBSTANCE).
Supervision of Documentation.
Shift planning manpower and material.
To ensure facilities cleanliness and man and material movement across the facility.
To involve in validation studies in coordination with cross functional departments.
To perform risk assessment and root cause analysis.
To train production personnel in all aspects of GMP.
To oversee IQ OQ PQ of new equipments in coordination with Eng and QA dept.
Change control management in coordination with cross functional dept.
Resolving the breakdown in coordination with respective utilities in charges.
Reprocessing activities of Albumin and IVIG resources planning and (Meeting Set
yields and Quality).
Fumigations and CIP of vessels scheduling on a regular basis.
Scheduling follow ups preventive Maintenance.
Preventive care to maintain Low levels of BET in product and equipment.
Chrom skid pH & Cond. Meter calibrations as required.
Packing and unpacking column with troubleshoot.
Trouble critical equipments problems as on when required.
Resources gathering and placing of order for the same.
Train Junior staff on technical aspects of columns / TFF / Centrifuge / Filtrations
Manpower management as required.
Plan and coordinate with vendor during AMC of Chrom Skids and Columns TFF SKADA
equipments.
Qualification and Skills:
Bachelor in Pharmacy Pharmaceutical science Life science or related field B.SC(Chemistry as one of the subject)
Minimum 38 yrs relevant experience
Ability to multitask prioritize workload and meet tight deadlines in a fastpaced and dynamic environment.
Knowledge and working experience in GMP CGMP GDP Documentations Audits
Team player as it involves managing a big team involving senior leadership
Excellent written and oral communication skills
Good articulation skills
Required Experience:
Manager
Employment Type
Full Time
