BASIC JOB TASKS INCLUSIVE BUT NOT LIMITED TO THE FOLLOWING:
- Carry out site inspections and audits to ensure site compliance.
- Preparing the site for external auditors.
- Document writing, reviewing, issuing and change control.
- Maintain CAPA system and ensuring deviations are closed timeously as per action plan.
- To ensure that all operational areas comply with the relevant cGMP requirements.
- To raise and review deviations where necessary.
- Trending and tracking of data to support product quality reviews.
- Ensure appropriate controls over materials management.
- Report on status of the quality system.
- To prepare batch release documentation of finished goods and intermediates when required.
- To assist with batch release procedure when required, including BPR review and updating Baan.
- To maintain relevant electronic databases.
- To present training that ensures compliance with cGMP principals.
- Carry out root cause analysis where required.
- 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 (Brief Summary)
- Excellent organizational skills.
- Ability to interpret regulations and make decisions.
- Ability to communicate with all levels of the business.
- Ability to work on their own initiative.
- Observation – ability to effectively observe and evaluate processes and procedures.
- Ability to prioritize and multi-task.
- Excellent problem solving skills.
- Attention to detail – proof reading and auditing.
Requirements
JOB REQUIREMENTS:
- Sc Degree in Chemistry or equivalent qualification.
- Thorough knowledge of cGMP and QMS.
- Previous cGMP experience in pharmaceutical or API manufacturing facility.
- Supervisory experience.
- Internal auditing experience essential.
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