Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Our client’s is seeking a highly motivated Sterile Manufacturing Scientific/Technical Writer job description which includes, but is not limited to:

Key Responsibilities:

Documentation and Compliance:

Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing.Participate and oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, batch records, Logbooks, and Laboratory Notebooks.Assist in the preparation of metrics and key KPIs for the area.Support the daily activities of the area to ensure the manufacture of quality parenteral products for development and clinical needs.Accountable for reporting and maintaining metrics as appropriate.

Technical Writing and Review:

Support the preparation, revision, and archiving of technical documents such as area rationales, templates, SOPs, equipment procedures, risk assessments, contamination control strategies etc.  Ensure zero instances of data falsification or data integrity issues by PPD staff.Generate and report metrics for Sterile Ops led processes.

Safety and Quality:

Inspect work area for safety regulations and recommend improvements.Identify and coordinate implementation of safety, quality, and business improvements.Assist and contribute to GMP and safety self-inspection activities.

Communication and Collaboration:

Proactively communicate the status of critical compliance systems support and problem resolution.Lead by example in working collaboratively and embracing GSK’s Code of Conduct.

Support and Training:

Provide technical support and participate as a Subject Matter Expert on GQP topics.

Continuous Improvement:

Apply knowledge and leverage continuous improvement activities to support adherence with industry regulations, Global Quality Policies, and business procedures.Lead the identification and implementation of strategies to improve the qualities and efficiencies of Sterile Ops processes and systems.Maintain strong systems/process understanding of current technologies and professional concepts.

Additional Responsibilities:

Strong understanding and application of aseptic manufacturing principles to implement new technologies/processes to the Sterile pilot plant.Application of knowledge and leveraging of continuous improvement activities utilizing available tools where applicable that support continued adherence with industry regulations, good documentation and data integrity principles.Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed to appropriate levels of Sterile Ops management.Responsible for scheduling and planning work to meet priorities set by GSK, setting specific daily and weekly priorities to meet timelines, and recommending procedures and policies to supervision.Employee may be asked to perform administrative tasks such as procedure revision, template revision, records filing, records archiving, and other tasks as needed.Employee has computer skills including Word, Outlook, and ability to navigate simple website interfaces.Employee must have good hygiene, practice good hand-washing behaviors, and be comfortable frequently using hand sanitizing agents.Employee may be asked to work occasional overtime hours.Must be a committed team player prepared to work in and embrace a team-based culture.Identifies risks to business for consideration by management.

Education:

Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with a minimum of 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job. Preferred understanding of GMP manufacturing.