Process Compliance Officer - Cape Town
Salary Negotiable
Cape Town,
Western Cape
more than 14 days ago
Location:
Western Cape
Deadline
5th August
Salary:
Market Related
BASIC JOB FUNCTIONS
• Compile, update and/or amend API Quality System documentation as required by regulatory authorities and internal customers.
• Compilation and updating of documentation for regulatory submission according to appropriate authority procedures and for use by customers.
• Drawing up periodic evaluation reports (e.g. PQR) by gathering, processing (graphically, statistically) and evaluating data, deliver conclusions and discuss the findings with relevant staff in order to determine appropriate actions.
• Support other standard or non-standard evaluation activities.
• Discuss and provide improved ideas on internal work processes.
• Report API production process improvement opportunities.
• Plan and document process improvement ideas and execution of projects.
• Maintain a deep understanding of the legislation and policies regarding process validation (life cycle) and annual product review / product quality review.
• Maintain theoretical knowledge of the following; all statistical tools used, a deep understanding of QMS processes and their interactions (change control, deviation control, specifications, stability etc.). Practical knowledge on the influence of (variation in) process execution.
• Comply with GMP requirements as outlined by Company SOP’s and written instructions in all tasks and activities.
• Adhere to all Company OHSE rules and regulations.
Personal Attributes
• Good interpersonal skills.
• Good organizational and systems implementation skills.
• Exceptional attention to detail and accuracy. The ability to critically evaluate data.
• Good written and verbal communication skills.
• Excellent report writing and document reviewing skills.
• Ability to perform tasks concurrently.
• Self-motivated.
Requirements:
• B.Sc. Degree in Chemistry or equivalent qualifications per the National Qualifications Framework (NQF).
• Able to work in matrix environment.
• Proficient use of statistical analysis methods.
• 1 year working experience within a Chemical/Pharmaceutical Manufacturing Environment
Should you not hear from us within 7 days, please consider your application unsuccessful.
Western Cape
Deadline
5th August
Salary:
Market Related
BASIC JOB FUNCTIONS
• Compile, update and/or amend API Quality System documentation as required by regulatory authorities and internal customers.
• Compilation and updating of documentation for regulatory submission according to appropriate authority procedures and for use by customers.
• Drawing up periodic evaluation reports (e.g. PQR) by gathering, processing (graphically, statistically) and evaluating data, deliver conclusions and discuss the findings with relevant staff in order to determine appropriate actions.
• Support other standard or non-standard evaluation activities.
• Discuss and provide improved ideas on internal work processes.
• Report API production process improvement opportunities.
• Plan and document process improvement ideas and execution of projects.
• Maintain a deep understanding of the legislation and policies regarding process validation (life cycle) and annual product review / product quality review.
• Maintain theoretical knowledge of the following; all statistical tools used, a deep understanding of QMS processes and their interactions (change control, deviation control, specifications, stability etc.). Practical knowledge on the influence of (variation in) process execution.
• Comply with GMP requirements as outlined by Company SOP’s and written instructions in all tasks and activities.
• Adhere to all Company OHSE rules and regulations.
Personal Attributes
• Good interpersonal skills.
• Good organizational and systems implementation skills.
• Exceptional attention to detail and accuracy. The ability to critically evaluate data.
• Good written and verbal communication skills.
• Excellent report writing and document reviewing skills.
• Ability to perform tasks concurrently.
• Self-motivated.
Requirements:
• B.Sc. Degree in Chemistry or equivalent qualifications per the National Qualifications Framework (NQF).
• Able to work in matrix environment.
• Proficient use of statistical analysis methods.
• 1 year working experience within a Chemical/Pharmaceutical Manufacturing Environment
Should you not hear from us within 7 days, please consider your application unsuccessful.