Basic knowledge of pharmaceutical industries, machine cleaning operation, and maintenance.
Understand workplace safety and related procedures (First aid)
Basic Knowledge of Pharmaceutical industries and their standards.
Good communication skills.
Knowledge of basic trouble shooting.
Standards, Process, and policies:
Basic understanding of cGMP, global quality standards, 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 the 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.
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.
Coordinate with cross-functional departments and participate in preventive and breakdown maintenance of equipment and machines.
Attend shift Communication meetings and Improvement project meetings.
Generate new ideas for workplace improvement and lockout on implementation.
Active involvement in the increase in Efficiency and effectiveness programs in departments.
Attend office as per shift schedule and maintain attendance as per requirement, leave shall be preapproved (Except and medical issues or emergencies)
Quality management and Compliance
Follow cGMP and safety at all stages of manufacturing activity.
Compliance with 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 control 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.
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.
