The major responsibility of the methodology specialist is to perform method validation and verification activities. Routine job responsibilities include the writing, reviewing and executing of method validation protocol and reports. The Specialist will coordinate and assist in investigative testing.
The Specialist will demonstrate technical expertise in QC functions and will provide expert levels of technical troubleshooting to the QC team. The Specialist will work in a detail-oriented, compliant manor in a fast-paced, environment, on multiple concurrent projects.
The Specialist is expected to adhere to tight deadlines with shifting priorities. The Specialist is expected to perform review of generated data for conformance to approved quality standards and must report any nonconformance or deviations to management in a timely manner for immediate required action.
The Analytical Method Validation 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:
Daily set-up, operation, troubleshooting and maintenance of instrumentation such as HPLC, UV, GC, KF, FTIR, and A.AS in accordance with written SOPs
Provides technical project support, participating in protocol development and execution for test method validation / verification and related activities
Provide expert level troubleshooting of laboratory equipment methods and process
Maintain lab work area and documentation in a neat and orderly fashion
Maintain data within a laboratory notebook in a legible, organized, and compliant manner, and transcribes or enters data into necessary records in an accurate and timely manner
Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management promptly for further investigation.
Performs investigative testing or other functions to assist with laboratory investigations.
Assists in execution of training and acts as a mentor to less-experienced analysts.
Works in support of development projects and may require weekend, off-shift work, or overtime as necessary to complete high priority work assignments
Interacts regularly with other departments including R&D, RA, and QA to ensure priorities are aligned and products are on track.
Reviews procedures and completes required documentation or updates as appropriate as part of Periodic review process
Manages projects to improve Laboratory compliance and efficiency.
Works on development of products, methods and projects to support R&D initiatives
Works with computers as well as laboratory software, or proprietary software as needed and ensure proper Laboratory Management
Follow GLP, GMP and safety procedures and maintain hygienic conditions in lab.
Ensure and perform Qualification, Calibration of Quality control and AS&T Instruments and Evaluation of column as per the Qualification, Calibration and Evaluation schedule
Fill the related SOP Attachment after performing the calibration and Label the Instrument
Reads and follows Equipment & Quality SOP s & follow safety during work and all plants.
Must ensure technical review of previously generated data for Regulatory responses.
Maintain and demonstrate a high level of personal and professional integrity and Report any suspicious activity to laboratory management.
Assists Laboratory Management on special projects and assignments
Additional responsibilities may be assigned by Laboratory Management as needed.
Maintain all system inspection ready & presenting Validation reports to internal & external audits.
Actively participate in continuous improvement initiatives.
Conduct & deliver On Job training wherever needed.
Bachelors ( 4 years) / Master s Degree in Chemistry & Pharmacy
Minimum 4-5 years of experience working in similar role in Pharmaceuticals industry.
Must possess strong project management experience
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
Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
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
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.
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.
Must be able to communicate technical, scientific, and regulatory information, both written and verbally
Ability to work in a detail-oriented manner
A Strong Background in Analytical Method Validation/Verification of In-House Method Development and Pharmacopoeia Drug Products.
Major Expertise in Chromatography, Dissolution and spectroscopy. Trained on FDA 21 CFR Part 210 and 211 regulations.
Knowledge in Chemistry and Pharmaceutical Drug Substances with a strong background in using Analytical Instruments like HPLC, GC, UV, Dissolution etc.., trouble-shooting and Maintenance of Chromatography and other analytical Instruments.
Proficient knowledge of USP and ICH guidelines of method validation and verification & Specification setting.