Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing your previously acquired knowledge.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Knowledge and skill
Technical skills:
Basic knowledge of pharmaceutical industries, machines cleaning operation and maintenance
Understand workplace safety and related procedures (First aid)
Basic Knowledge on Pharmaceutical industries and its standards
Good communication skills
Knowledge on basic Trouble shooting
Standards, Process and policies
Basic understanding of cGMP, global quality standard and Data Integrity
Behavioral/ any Other skills:
Attention to details
Willingness to take direction and adhere to procedures
Basis understanding of hygiene, Clean room work culture
Proper utilization of personal protective equipment during activities
Responsibilities
Equipment installation and qualification
Participate in the installation, site acceptance test, Installation qualification, operation qualification, process qualification and re-qualification of equipment in the respective functional area
Participate in the execution of equipment qualification, performance verification and process validation
Ongoing Operation
Maintain personnel hygiene while coming to office and entering in working area
Beware of and always adhere to change room procedures
Check for proper housekeeping in his/ her area and follow all time audit readiness practices
Receive and maintain the daily consumables
Operate the Automatic and manual Visual Inspection as per the procedures and execute the batch according to the BMR
Perform the cleaning of the inspection booth and all equipment’s as per procedures
Lux reading must be taken before performing the activity as per the procedures
Perform the inspection, segregation and labelling as per procedures on Automatic inspection machine
(Bosch/ Eisai), leak detecting machine (Nikka/Wilco), semiautomatic inspection machine (Maschinpex), Manual inspection booth and APK
Achieve the desired output in lines as per shift, week, monthly and yearly target assigned
Issues to be escalated to higher authorities immediately when identified
Accountable for area and equipment upkeep
Perform the cleaning and sanitization of area and equipment as per procedures
Handle waste and rejects as per procedures
Hand over the shift at the end of shift and to take charge of the shift
Coordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machines
Attend shift Communication meetings and Improvement projects meeting
Generate new idea for workplace improvement and lookout on implementation
Active involvement in increase in Efficiency and effectiveness programs in departments
Follow procedure for proper material movement from SFG area to Inspection area and from inspection area to SFG/FG area with proper status label
Handling of rejects generated in process with proper status labelling
Attend office as per shift schedule and maintain attendance as per requirement, leave shall be preapproved (Except medical issue or emergency)
To complete inspector qualification and re-qualification activities on time without overdue and ensure to not involve in any activity if validity is crossed
Complete all site specifics trainings and global trainings assigned in to do list as per requirement
Follow proper material and product movement in area pre-inspection and post inspection
Perform loading and unloading of product on machines
Part of continuous improvement meetings and add necessary inputs for improving efficiency and compliance
Documents the defects observed during inspection process properly in forms online and accountable for handling documents in area
Quality management and Compliance
Follow cGMP and safety at all stages of manufacturing activity
Compliance to Pfizer integrity principles at all stages of manufacturing
Participate in internal and external (Regulatory and Non-regulatory) audits
Documentation
Prepare the daily activity report. Complete the documents online as per cGMP and GDP
Preparation of user requirement specification (URS), Standard Operating Procedures, change controls, forms and corrective action and preventive action and support investigation
Responsible for protocols preparation execution, completion, review and submission and retrieval to documentation team and validation as per requirement
Training
Attend training for all the applicable procedures as per the schedule before performing the job
Should be able to provide training to the trainees
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Manufacturing
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