KVK Tech is hiring: GMP Technical Writer in Newtown

Department

Technical Services

Job Title

GMP Technical Writer

FLSA Status

Exempt

Role

N/A

Sub Role (If any)

N/A

Reports To

Technical Services Supervisor

1. Role Purpose:

This individual is responsible for providing technical and proposal writing support to the Technical Services division. Additionally, the position will also assist with development and delivery of process records for production. Additionally, writing investigations and Standard Operating Procedures, Technical Transfer Documents, and Validation reports. Execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs and SOPs.

2. Key Duties & Responsibilities:

• Develop, write and review of technical documentation which includes manufacturing/packaging batch records.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Manage the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
• Develops, writes and reviews/updates SOPs.
• Prepares various summary forms for Pharmaceutics related projects as well as graphs, charts and statistical analysis for establishing product specifications.
• Designs, develops and implements databases to track key project deliverables and resource allocation within Pharmaceutics and updates on an ongoing basis.
• Provide investigation expertise and technical writing expertise to perform and document process Deviations and Events.
• Implements Change Control management in production and engineering.
• Review and approve documentation associated with cGMP Compliance. Assess and document product quality impact.
• Assist regulatory to provide technical documentation for submission.
• Assists with the development of departmental project timelines and project plans.
• Other duties as delegated.

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Education Requirement

Specialization (If any)

Bachelor’s degree in chemical engineering Preferred

Experience Requirement

N/A

Number of Years

1-3 Years

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

• Preparation and approval of Standard Operating Procedures.
• Preparation and review of Quality Risk Management for process, area and equipment.
• Experience with quality improvement initiatives as needed.
• Experience with development/writing of SOPs or other quality documents and/or reports as needed.
• Complies with company policies and SOPs.
• Good written and oral communication skills.
• Experience in statistical analysis, process capability reviews with software.
• Ability to act independently.
• Strong organization skills, attention to detail, and the ability to work in a team, fast paced environment.
• Excellent interpersonal, verbal and written communication skills

Certifications

N/A

Licenses

N/A

Other

N/A

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A