To author technical documents such as analytical methods, specifications, validation protocols validation reports, transfer protocols, SOPs accordingly to the company’s standards and FDA /ICH guidelines. To review USP changes in a timely manner and update the related documents to implement the changes.

Area Of Responsibility

• Oversees method/specification and Laboratory SOP creation process.
• Writes/review/approve technical documents such as method, specifications, validation protocols, validation reports, transfer protocols and reports, SOP’s based on corporate policies, compendia requirements, ICH and FDA guidelines.
• Initiate and review the change controls for method/specification and SOP revisions and ensure they are closed on time.
• Communicate the cross function team about changes in specification and method.
• Evaluate the specification and method changes performed by vendor and ensure their appropriate implementation.
• Shared the specification and methods will cross function team for review and approval.
• Perform the actions assigned as part of CAPA.
• Control the Mater copies of method and specification.
• Issue the control copies to QC for use, maintain appropriate documentation and ensure retired copies are archived.
• Evaluates compendia documents, and reviews procedures for analytical development and validation.
• Must have an appropriate understanding of ICH and FDA regulatory guidance’s needed to prepare documents properly.
• Assigns document numbers. Maintains hard copies and electronic files of technical documents.
• Communicates with raw material manufacturer for any technical information.
• Provide the documents required for CBE, PAS and ANDA submission to RA in a timely manner.

Work Conditions:

Manufacturing/Production environment

Environmental related to manufacturing/production environments:

• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
• Odors: Unpleasant smells.
• Gases: Examples include carbon monoxide and ozone.
• Dust: Airborne particles of any kind, such as textile dust, wood, and silica.

Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.

Physical Requirements:

• Moderate physical effort equal to frequent lifting or moving of lightweight materials up to 10lbs.
• Ability to navigate office and plant floor working environments, stands, ambulates, and reaches.
• Ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/googles, and safety shoes.

Travel Estimate

Up to 5%

Education and Job Qualification

• Minimum of a B.S. in a scientific field.
• Must have worked as chemist with hands on experience in wet chemistry analysis and analytical instruments like HPLC, GC, dissolution etc.
• Excellent computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access.
• Strong written and oral communication skills.
• Hands on experience with TrackWise, LIMS and Document Management System.
• A self-starter with a hands-on approach and a can-do attitude.
• Excellent project management and problem solving skills.
• Must be able to work independently.
• Must have an understanding of FDA and DEA regulations.
• Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills.
• Collaborates with colleagues and external partners to achieve primary Department goals.
• Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management.
• Works in coordination with project plans and goals as assigned by Management.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

Experience:

• Minimum eight (8) years of experience in pharmaceutical analytical laboratory along with technical writing.