Regulatory Affairs Scientist - Epping, South Africa - Aspen Pharma Group

Aspen Pharma Group

Verified Company

Epping, South Africa

2 weeks ago

Posted by:

Thabo Mthembu

beBee Recruiter

JOB REQUIREMENTS:

Degree in Chemistry/Chemical Engineering or equivalent qualification.
Good knowledge of chemistry (Analytical and Organic). Statistical knowledge would be advantageous.
Minimum of 1 year experience in pharmaceutical, cGMP or chemical manufacturing environment.
Proven technical documentation compilation skills, with the ability to critically evaluate and interpret data.

JOB FUNCTIONS (Brief Summary)

Compilation and/or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations.
Performing risk assessments to evaluate the potential presence of elemental, genotoxic and/or nitrosamine impurities according to relevant regulatory guidelines.
Compilation of process qualification protocols and reports.
Investigating, evaluating and reporting on process performance and proposed changes.
Ensuring that annual product quality reviews are compiled according to cGMP standards and adverse trends and potential process improvements identified.
Implementing changes according to established company procedures relating to the testing and manufacturing process.
Compilation and update of documents to be submitted to Regulatory Authorities. This includes compilation of Common Technical Documents.
Ensuring that related databases are updated to allow for the capturing of API data.

PERSONAL ATTRIBUTES (Brief Summary)

Good interpersonal skills.
Good organisational and systems implementation skills.
Exceptional attention to detail and accuracy.
Good communication (written and verbal) in English with excellent report writing and document reviewing skills, including the ability to evaluate data critically.
Ability to perform tasks concurrently.
Selfmotivated.