Quality Control Supervisor (Epping) at Aspen Pharma Group

Description

• Fine Chemicals requires the services of a highly competent Quality Control Lab Supervisor for the Quality Control Department.  To qualify for this position suitable candidates must fulfill the following requirements

Requirements

JOB REQUIREMENTS:

• Must have a BSc in Chemistry or a National Diploma in Analytical Chemistry or equivalent  
• A minimum of 5 years of pharmaceutical experience in a quality laboratory environment with at least 2 years in a leading role.
• Additional courses in GLP, ISO17025, and statistical data analysis would be advantageous
• Additional knowledge of validations, stability testing, and technical support development is necessary
• Thorough knowledge and understanding of cGMP (current Good Manufacturing Practice) and the manufacture of Active Pharmaceutical Ingredients (API’s)
• Must be computer literate in using the MS package as well as LIMS, Veeva Docs, and SAP
• Must be able to lead a team of analysts on a shift rotational basis
• Have good knowledge of processes and procedures to be able to support Analysts with troubleshooting and data analysis.
   

JOB FUNCTIONS (include but not limited to):

• Follow testing deadlines provided by the Operations Planners establishing testing deadlines based on business needs and current capacity
• Liaise with all operational leads
• Ensure that testing of in-process samples is done in accordance with existing SOPs.
• Communicate any conflicting priorities and delays to QC Manager and Operations
• Concurrently review sampling and testing operations as well as results generated, any excursions are investigated either via the PIF or deviation system in the shortest possible timeframe, preferably for sample OOS/OOT this must be done before moving on from the current testing system.
• Reviewing and amending of testing methods and SOPs as per the relevant regulatory requirements
• Develop and train staff, manage employee performance, and timekeeping, recruitment of staff, and maintain staff discipline.
• Where necessary, ensure that RM's are released to production as and when needed. 
• Timeous investigation of out-of-specification results/batches
• Ensure that all testing and relevant logbooks are reviewed
• During the review of data, ensure that documents in your section are current for the operations to be performed as per the relevant regulatory requirements. QA/RA of obsolete documentation or necessary changes.
• Implementation of corrective action identified in deviation reports and audits
• When necessary, carry out support testing, data analysis, and checking.
• Documentation control and reviews.
• Implement CAPA programmes where deficiencies are identified
• Attend production exception meetings when required
• Ensure the laboratory is maintained in a GMP state as required by the relevant regulatory authorities.
• Ensure all HSE requirements are complied with in the QC Laboratory.

KNOWLEDGE, SKILLS AND EXPERIENCE:

• Excellent, leadership qualities, ability to motivate laboratory analysts, and the willingness to take responsibility when problems arise
• Good organisational and documentation skills
• Good written and verbal communication
• Good interpersonal and negotiating skills
• Ability to solve problems and troubleshooting in a logical, systematic, and scientific manner
• Sound knowledge of the testing methods and instrumentation used in the QC laboratory 

PERSONAL ATTRIBUTES:

• This position calls for a highly motivated and enthusiastic team player with excellent communication skills, someone who can exercise their initiative and who has a desire and a talent to motivate, coach, develop, and guide others in a team-based environment.
• Can problem-solve, take initiative, and implement improvement projects in conjunction with other work centres
• Willingness and ability to work after hours/overtime when required