Business Title: Documentation Reviewer
II Effective Date/
Last Modification Date: 28. JUN. 2021
Summary:
Responsible for individually reviewing numerous technical reports and raw information produced in Lab
Operations.
Important Functions:
Reviews separately all routine technical files (e.g., batch testing, stability testing and approach
recognition) and raw information created in the labs with high quality and deliver within concurred
schedule.
Ensures the test techniques, procedures and Standard Operating Procedures (SOPs) have been followed
by the scientists/chemists.
Confirms the integrity and traceability of all information produced and reported.
Follows up with scientist/chemists/technicians to guarantee that all necessary corrections are remedied in
accordance with Good Manufacturing Practices’ requirements.
Alerts department supervisor/manager relating to omissions, insufficient testing outcomes or other
irregularities.
Might be required to take a trip to various websites depending on business requirements (as required)
May be necessary to carry out alternating or rotating shift work (as needed).
REQUIRED QUALIFICATIONS
Education:
Bachelor of Science in Chemistry or associated science.
Experience:
Minimum 3 years of previous pharmaceutical analytical advancement experience.
Minimum 3 years of Empower Software experience.
Previous document customer experience preferred.
Knowledgeable about present ALOCA concepts.
Equivalency:
Equivalent combinations of education, training, and pertinent work experience might be thought about.
Knowledge, Skills and Abilities:
Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography
(HPLC), Gas Chromatography, Ultraviolet (UV) spectroscoy, titration, and basic material screening. Excellent
written and oral interaction skills. Great working knowledge of Good Manufacturing Practices,
International Conference of Harmonization (ICH) and United States Food & & Drug Administration (FDA)
requirements. Strong organizational abilities and detail oriented. Ought to have GMP chromatography
experience (Specifically EMPOWER is an asset). Direct pharmaceutical experience in a GMP environment.
Ability to satisfy deadlines and prioritize. Shown computer efficiency with Microsoft Office programs.
Proficiency with the English Language.
Core Competencies:
Put the Customer First – Think and show a customer-centric mindset to provide exceptional client
experiences. Own Your Results – Take individual responsibility for all you do and always work out good
judgement. Discover a Better Way Everyday – Be intellectually curious and accept Practical Process
Improvement (PPI).
Standards and Expectations:
Follow all Environmental Health & & Safety Policies and Procedures. Work collaboratively with fellow team
members, designing positive team principles and partnering to fulfill job and departmental goals.
Perform all duties within strict compliance to Patheon quality systems SOP’s and Good Manufacturing
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Documentation Reviewer II Page 2 of 3
Practice (GMP). Keep work area in a tidy and orderly fashion. Actively take part in and comply with
department systems in order to keep a smooth and efficient workflow (visual management, scheduling
systems, and so on). Be client and patient conscious at all times. Understand Key Performance Indicators (KPI’s)
and make every effort to improve the efficiency of the group by recognizing areas for system improvements and
take part in issue fixing. Designs favorable thinking and is open to alter, motivating the group to adjust
to shifts in priorities and brand-new ways of working. Proactively recognize locations for improvement in the execution
of treatments. Interact risks to timelines in a proactive way. Regularly makes every effort to improve abilities
and understanding in related field.
Physical Requirements:
Position requires normal ambulatory skills and physical coordination adequate to move about lab/lab office
areas; capability to stand, stroll, stoop, kneel, crouch occasionally for extended amount of times; adjustment
(lift, bring, move) of light to medium weights of 10-35 pounds; arm, hand and finger mastery, including
ability to grasp and type for extended periods of time; visual skill to utilize a keyboard, computer screen,
operate equipment, and read products for prolonged periods of time; ability to sit, reach with hands and
arms, talk, and hear for extended periods of time. Usage of Personal Protective devices may be needed
and might consist of any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety
apron, organic respirator sometimes.
Disclaimer:
This job description is intended to provide the general content and requirements for the efficiency of this
task. The description is not to be interpreted as a comprehensive statement of work, obligations, or
requirements. Managers and managers might assign other tasks as required.
Absolutely nothing contained herein must be construed to create an employment agreement. Sometimes, needed
skills/experiences for tasks are revealed in quick terms. Any language included herein is planned to fully
align with all obligations enforced by the legislation of each country in which it operates, consisting of the
execution of the EU Equality Directive, in relation to the recruitment and work of its workers.