Quality Control Lab Trainer & Snr Analyst (Epping) at Aspen Pharma Group

Description

• Fine Chemicals requires the services of a highly competent QC Lab Trainer & Snr. Analyst for the Quality Control Department.

Requirements
JOB REQUIREMENTS: 

• Minimum Educational requirement is a ND/BTech or BSc Degree in Chemistry or equivalent
• Coaching or Trainer the Trainer Course will be advantageous.
• Minimum of 3-5 years of practical experience in a Pharmaceutical Quality Control Laboratory.  
• Thorough knowledge and understanding of cGMP (current Good Manufacturing Practices) and quality control requirements pertaining to the manufacture of Active Pharmaceutical Ingredients (API’s).
• Knowledge of international regulations governing the manufacture of API’s.
• Ability to carry out investigations and must have good troubleshooting skills.
• Must have knowledge of the API Testing Environment and the policies and Procedures involved.
• Must be computer literate and able to use various operating systems and software programs, i.e., Chromeleon.

BASIC JOB FUNCTIONS:

Operational Tasks (not limited to):

• Testing of raw materials, finished products, and in-process samples.
• Checking the accuracy and validity of raw data.
• Testing according to USP/EP Pharmacopoeia, in-house, and customer standards.
• Perform analysis using appropriate equipment and related techniques
• Provide detailed observations from the analysis of data and interpretation of results.
• Training and developing department employees on Standard Operating Procedures (SOPs), Work Instructions, General Methods, Policies, and cGMP in accordance with ICH, FDA, and MCC guidelines.
• Carry out gap analyses of QC team members as part of PDP (Personnel Development Plans) and monitor key performance Areas
• Adhere to and improve on stipulated lead times, which should result in continuous improvement.
• Maintenance of GLP and audit readiness in the Laboratory
• Involved in audits/inspections and should be able to respond to auditors/inspectors and regulators when training is audited.
• Check the availability of all consumables before analysis and ensure that all system suitability requirements are met.

Document Control and Traceability (not limited to):

• Maintain, create, or amend SOPs, working instructions, policies, and standard forms for the QC department using the Document Control system, namely Veeva Docs (QDocs).
• Liaise with stakeholders (vendors and in-house) to have training implemented in QC.
• Perform analytical investigations according to the SOP on out-of-specification (OOS) results.

GMP (not limited to):

• Complete all records and reports timeously and accurately as described in the relevant SOPs, protocols, and associated documentation.
• Ensure that products are stored according to the required SOP's and documentation.
• Ensure all sections within the department maintain compliance with company GMP standards.
• Ensuring training records are in a GMP state.

Health, Safety, and Environmental Standards (not limited to):

• Carry out any duty or requirement imposed on the company by the OHS Act, and in accordance with your specific SHE appointment.
• Report any incident to the SHE representative or Line Manager that may affect your health or cause injury.
• Ensure routine inspections, investigations, and incident reports are conducted as required and concluded in a timely manner. 

PERSONAL ATTRIBUTES (Brief Summary):     

• Very good organisational and record-keeping skills.
• Exceptional attention to detail and accuracy.
• Good communication skills (written and verbal) as well as accurate report writing and document reviewing abilities.
• Motivated, positive, and work well in a team environment
• Willing to work after hours, overtime, and shifts if operationally required.