Job Description

Job Title: Consultant - Technical Writer

Job Description:

We are seeking a highly skilled and motivated Consultant to support the implementation and maintenance of quality systems documentation and technical documentation within a regulated environment. The ideal candidate will have experience working with Batch Records, GMP SOPs, Validation Reports, Quality Assurance SOPs, Calibration, Validation Protocols, and I/O/P Qualifications. This role will focus on the implementation of material management and control, quality release of raw materials, vendor qualification, as well as sterility and gowning procedures and qualification.

Key Responsibilities:

• Draft, review, and approve documentation required for the receipt of radioactive materials into the facility, meeting company objectives.
• Successfully manage the implementation of the supplier qualification program and raw material quality management systems.
• Create and develop a compliant radiopharmaceutical and nuclear medicine training program for the site.
• Lead efforts to decrease the number of review cycles and streamline generation timelines for quality and technical documentation.
• Foster a strong quality culture surrounding documentation, training, and compliance to enhance overall GMP effectiveness.
• Provide guidance and authorship for high-level procedures and work instructions.
• Lead compliance projects and serve as the primary point of contact for Quality Assurance (QA) regarding the implementation of quality systems and technical documentation.

Qualifications:

• Proven experience in quality system documentation, including Batch Records, GMP SOPs, Validation Reports, and related technical documentation.
• In-depth knowledge of material management, raw material quality release, and vendor qualification.
• Experience in sterility and gowning procedures and qualification.
• Strong communication and leadership skills, with the ability to manage and collaborate with cross-functional teams.
• Ability to work efficiently under tight deadlines and manage multiple projects simultaneously.
• Familiarity with GMP standards and regulatory requirements within the pharmaceutical, radiopharmaceutical, or nuclear medicine industries.

If you are passionate about quality systems and technical documentation, and enjoy driving compliance and efficiency, we encourage you to apply for this exciting opportunity.

Job Tags

Similar Jobs