The Specialist Instrumentation will adhere with the cGMP principles and maintain them in effective manner. He will perform periodic testing and calibration as per approved schedule and SOPs.
He will perform instrument related maintenance as per plan and procedures. Primarily responsible for ensuring adherence to computer validations, data integrity standards, and procedures for computer related analytical laboratory instruments.
Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, and provides timely and effective response and follow-through in issue resolution during installation and qualification activities. Ability to effectively communicate and multitask.
The instrumentation specialist will report to Analytical Science & Technology Manager and efficiently conduct all duties and responsibilities assigned and or delegated by the AS&T Manager.
Key responsibilities & Accountability:
Confers with engineers, supervisor, and other technical workers to assist with equipment installation, maintenance, and repair techniques.
ensure proper division of work & responsibility among the instrumental engineers, providing proper guidance & integration of work done, ensuring good, positive & healthy working nature among the team of engineers to ensure optimum productivity & efficiency.
Perform Calibration & Qualification of all analytical equipment as per the calibration master plan.
Pressure, temperature, flow, and level installation, calibration, and maintenance experience. Understanding of operations, safety considerations and applications for common analytical instruments including pH, Conductivity. Understand analog, digital, and relay field wiring and troubleshooting. SQL server experience.
Follow the calibration Procedure and perform the test / calibration by using Certified standard in his responsible Labs.
Prepare Calibration SOP, Calibration Documents and arrange it properly.
Fill the related SOP Attachment after performing the calibration and Label the Instrument.
Preparing protocols & reports.
Prepare work orders and complete necessary reports.
Enter all the calibration details into SAP system.
Preparation & Issue of RFQ s, evaluation of vendor s quotations, clarifications, Technical Bid Analysis etc. for all the required process aspects.
Review of vendor s documents, drawings, datasheets, specifications and calculations for all the required process aspects.
Performs preventative maintenance and troubleshooting on all analytical instruments in QC, RnD & IPC.
Install, repair, replace equipment such as relays, switches, supervisory controls, indicating and recording equipment.
Maintain equipment lifecycle management & ensure to follow operation & maintenance SOP s.
Follow safety during work in all plant.
Actively participate in continuous improvement initiatives.
Conduct & deliver On Job training wherever needed
Bachelors ( 4 years) / Master s Degree in Engineering
Minimum 4-5 years of experience working in similar role in Pharmaceuticals industry
Has experienced using computerized maintenance system (SAP)
Experience with computer system validations including leading, developing and implementing validation strategies and authoring required validation documents.
Experience qualifying analytical laboratory instrumentation (eg HPLCs, Spectrophotometers, FTIRs, etc.)
High on communication and collaboration , having an ability to manage multiple stakeholders at a time
In terms of competency you are highly result oriented with strong sense of accountability & ownership.
Must be able to manage tasks and priorities and easily adapt to changing situations.
Good command in English (Communicating, writing and speaking)
Good prioritizing skills and being able to make a just decision also in case of (time) pressure;
Strong organizational skills and the ability to multitask
Demonstrated ability in working independently and as part of a team
Strong Analytical skills and should be self starter who needs limited supervision
Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
Must be able to communicate technical, scientific, and regulatory information, both written and verbally
Ability to work in a detail-oriented manner
Ability to meet attendance standards. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.
Must have a teamwork attitude & ability to apply common sense understanding to carry out multi- step instructions
Deal with standardized situations with occasional variables
Must be highly organized, self-motivated to learn new things and implement them in building or updating quality system for Pharmaceuticals.
Flexible learning abilities & Proficient in technical writing
Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word
Ability to interpret data utilizing intermediate math operations; perform complicated analytical calculations and statistical analysis
Ability to write or speak in the English language and communicate information effectively in one-on- one and in a group of employees within the organization.
Knowledge in Electronics Engineer with a background in Analytical Instruments installations, trouble- shooting and service Maintenance. Major Expertise in Chromatography and spectroscopy.
Background in Analytical Instruments installations, trouble-shooting and service maintenance.
Major Expertise in Chromatography and spectroscopy.
Strong Knowledge of cGMPs and data integrity requirements (21 CFR Part 210/211, Part 11) and analytical instrument qualification (USP 1058).