01) Manufacturing of Parenteral dosage forms
02) Preferably experiences in good understanding of manufacturing and quality systems
03) Handling, Storage and reconciliation of materials
04) Technical knowledge on terminal sterilization of the products with respect to microbial lethality
05) Knowledge on D value, F0 value, Z value calculation and sterilization cycle
06) Good documentation practices and data integrity
07) Ability to write and revise standard operation procedures and related manufacturing documents
08) Strong interpersonal skills communication skills
09) Analytical thinking to grasp complex technical issues and provide feasible solutions
10) Decision making on activities in the area according to GMP procedures
11) Ability to communicate effectively with all levels within the organization
12) Ensure terminal sterilization as per procedures
13) Activity planning and deploying the personnel according to the plan
14) Ensure area upkeep with adequate identification of machines and materials
15) Conduct real time batch record review in assigned area
16) Enforce discipline of the personnel working in the process area
17) Ensure compliance of change room behavior and personal hygiene to procedures
18) Ensure adequate cleaning, sanitization of the equipment and area and housekeeping
19) Ensure avoidance of cross contamination and / or mix ups
20) Coordinate supporting functional departments for smooth operation of production activity
21) Ensure all the performed activities comply with respective procedures
22) Ensure the completeness of documentation for all performed activities
23) Initiating CCFs related to documents, equipment. Ensuring their closure and implementation of the changes within specified time
24) Ensure training compliance for house keeping personnel / contractors as per the requirement
25) Identify deviations / exceptions and escalate to manager by appropriate procedures
26) Active participation in the investigations related to exceptions and during equipment maintenances
27) Disposal of rejects and waste generated during processing and other related activities
28) Initiate and assist with investigations as applicable
29) Monitor assigned area for compliance to SOPs and c GMP
30) Adherence to safety procedure / GMP GDP practices
31) Preparation of trial run protocols related to exceptions
32) Raise requests to Engineering in the event of break down / Maintenance - Certify the same after completion
33) Ensure compliance of operations to c GMP and safety practices at all stages of activities
34) To participate in internal external ( Regulatory Non - Regulatory) audits
35) To Prepare the procedures pertaining to area in compliance to regulatory requirements
36) Ensure documents pertaining to the respective area of work is on - lines as per c GMP and GDP
37) Submit the documents to the documentation cell on time
38) Should be able to work in all shifts and to prepare the daily activity report
39) Complete the training of all applicable procedures as per schedule
40) Training the team on relevant procedures and getting trained on respective area of work
Keyskills: Process design Training Housekeeping Compliance Analytical Pharma Quality systems Reconciliation Agile GMP
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We re looking for new talent to join our global community, to unearth new innovative therapies that make the world a he...