Job Description

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

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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