R&D Document Reviewer

at  Bimeda

Cambridge, ON, Canada | Full-time regular
Posting Date : 2024-07-18
Job Identification : 200
Department : Research & Development

SUMMARY:

The R&D Document Reviewer works closely with the R&D team and performs verification on analytical results and final reports generated by other R&D Chemists. The Document Reviewer also performs internal audits and process troubleshooting to ensure the lab operations are carried out according to approved procedures and in accordance with GMP/cGMP requirements.

CORE BEHAVIOURS, SKILLS & ABILITIES:

• ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
• INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
• COORDINATION – manages cross-team projects successfully; adapts to the people around them; meets deadlines
• FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
• EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others.
• NEGOTIATION – Is the ability to know how to get what you want; understands the win-win relationships; understands each party’s interest in the situation.

• Performing timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP, compliance, and neatness of analytical documentation.
• Verify calculations and documented information including, but not limited to, reagent expiry, instrument calibration, logbook entries, and control charts. Ensure that this information is complete and accurate.
• Verify that all analyses performed were as written methodologies and/or compendia methods, and were in compliance with GMP requirements.
• Perform internal audits ensuring that lab operations are carried out according to approved procedures and in accordance with GMP/cGMP requirements.
• Conduct, or assist in, out-of-specification and deviation investigations
• Audit and review data for accuracy, completeness and regulatory compliance
• Assist laboratory with regards to Out-of-Specification investigations, exceptions, and corrective actions
• Other duties as assigned.
  Requirements:

Essential:

• At least 5 years of drug experience developing methods in a GMP environment, Experience with the requirements of ANDA, ANADA, IND, and INAD submissions is desirable.
• Minimum B.Sc in technical field or scientific discipline (Biology, Biochemistry, Chemistry) is required.
• HPLC and GC techniques, wet chemistry techniques.
• Good written and verbal communication skills are required.
• Good organizational and troubleshooting skills are required.

• Self-motivated and committed to a team approach.Strong interpersonal and organizational skills.