Porton Pharma Solutions Ltd. is a leading pharmaceutical CDMO company that provides global pharmaceutical companies with innovative, reliable, and end-to-end process R&D and manufacturing services across small molecule APIs, dosage forms, and biologics. We are looking for a GMP Operations Documentation Specialist.

Job Title: GMP Operations Documentation Specialist

Prerequisites

· BA/BS degree or equivalent is required.

· Experience within the pharmaceutical industry in a GMP regulated facility for at least 4 years preferred. Extensive knowledge of USP, ICH, FDA, 21 CFR and other guidance documents.

· Ability to commute between South Plainfield and Cranbury NJ sites as needed.

Responsibilities

· This position is responsible for supporting J-STAR’s Quality System for the manufacture, of APIs and intermediates in accord with GMP regulations and related FDA/ICH guidelines. The responsibilities of the position include, but are not necessarily limited to, the items listed below:

o Support management and maintenance of the GMP operations SOP and Document Control system

o Prepare, review, and execute GMP documents.

• Organize and maintain equipment logbooks
• Track preventive maintenance and calibrations/qualifications to ensure all GMP equipment and instruments are in-date

o Support compliance projects such as management of quality issues, CAPA projects, or other cross-functional initiatives

• Help prepare for and participate in GMP audits as needed
• Track the periodic review status of production SOPs to ensure that they remain up-to-date
• Research production/processing equipment or fixtures for purchase and gathers data relating to their ability to meet organizational needs
• Develop, maintain, and provide training for J-Star personnel on GMP related processes and procedures
• Manage GMP kilo lab and equipment reservation, check out, clean out and check in processes

Qualifications

· Proven track record of setting and meeting aggressive targets and timely execution of objectives.

· Excellent written, verbal and communication skills.

· Ability to prioritize and manage numerous projects simultaneously.

· Ability to interact in an effective and appropriate manner with diverse population sets.

· Ability to communicate candidly, clearly, and timely.

· Experience in working on, positively contributing to, and leading teams.

· Proficient in Microsoft®Office™and other job-related software and applications.

· Ability to perform the physical requirements of the position. Must be able to walk, stand, stoop, crouch, bend or reach above and below shoulders height frequently. This job requires twisting and turning of the body and the use of both hands.

Reporting Relationship

· Reports to Associate Director or Director of GMP Operations

Primary Location: South Plainfield and Cranbury, New Jersey, USA

Job Type: Full Time

Job Type: Full-time

Schedule:

• 8 hour shift

Ability to Relocate:

• East Brunswick, NJ: Relocate before starting work (Required)

Work Location: In person