QC Compliance Specialist

Job Summary

Under limited supervision, manages laboratory compliance activities for assigned functions and projects. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Prepare and review the technical and compliance documents such as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOP’s accordingly to company’s standards and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes on a timely basis and update the related documents to implement the changes and ensure the compliance.

Area Of Responsibility

• Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies and SOP's, compendial, ICH and FDA regulatory guidance.
• Ensures that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
• Evaluates compendial documents, and reviews procedures for laboratory compliance. 
• Evaluate Sun global documents (GQS and GSOP) against site specific procedures and update the site procedure accordingly.
• Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards.
• Generates change requests required for analytical documents, and routes documents for review and approval. Maintains hard copies and electronic file of technical documents.

• Timely provide the QC documents required for CBE, PAS and ANDA submission to RA.         
• Collaborates with colleagues and external partners to achieve individual and department goals.
• Ensure compliance with cGMP’s, DEA regulations and site operating procedures under the direction of QC Management.
• Ensure Lab Event/Out-of-Specification and Out-of-Trend investigations are properly conducted and closed on a timely fashion.
• Ensure continuous laboratory compliance by adopting best industry practice and complying with procedure requirements.

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:

• Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl.
• Close vision; depth perception; ability to adjust focus
• Use of repetitive motion
• Able to operate computer/office machines
• Able to lift and carry up to 50 lbs.

Travel Estimate

Up  to  5%

Education and Job Qualification

• Minimum BS or equivalent degree in Chemistry or related discipline.
• Good computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access.
• Must have an understanding of FDA guidelines, ICH guidance and DEA regulations. Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management.
• Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills.
• Must have cGMP compliance knowledge and experience.
• Collaborates with colleagues and external partners to achieve primary Department goals.
• Works in coordination with project plans and goals as assigned by Management.
• Demonstrated strong communication: verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• Excellent project management and problem solving skills.
• 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 of four (4) years of experience in the pharmaceutical industry.