Job Description :
Why Patients Need You
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
- Manage own time and professional development, be accountable for own results and begin to prioritize own workflow.
- Responsible for the preparation and/or operation of various components, materials, equipment, machines including, but not limited to any and/or all applicable components, materials, equipment, machines in the assigned area(s).
- Complete adherence to all plant safety and (current) Good Manufacturing Practices also cGMP regulations to the highest.
- Assist with diagnosis and troubleshooting activities and execute in-process quality inspections.
- Ensure adequate inventory of parts and materials prior to initiating a production run.
- Identify and seek to implement process and safety improvement and perform all tasks in a safe manner.
- Participate in shift meetings, provide hand off information and communicate with other units and shifts.
- High School Diploma or GED
- 2+ years of experience
- Demonstrates ability to properly problem solve work-related issues, exercise good judgment/decision making, and effectively work with team members
Knowledge and skillTechnical skills:
- Bachelor's Degree
- Previous experience in cGMPs (current Good Manufacturing Practices) environment
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 validationOngoing 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.
Error 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 lockout 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 and medical issue or emergency)
To complete inspector Qualification and Re-qualification activities on time without ant past due, if validity is crossed not to involve in any activity. Ensure qualification status.
Complete all trainings site specific and global training assign 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 preventative action and support investigation.
Responsible for protocols preparation execution, completion, review and submission and retrieval to document cell and validation as per requirement.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Manufacturing#LI-PFE