Validation Manager at Adcock Ingram

Key Job Output

Legal compliance to SAHPRA/PICs, cGMP requirements and Pharmacy Council requirements.

• To ensure that all validation related audit points identified during internal and external audits are closed timeously.
• To ensure that new and updated Guidelines and Policies from  SAHPRA and other Regulatory bodies related to pharmaceutical industry are used at all times when developing internal documentation.

Qualifications and Validations

• Compiling and updating  a Validation Master Plan (VMP) and relevant Validation Plans (VPs).
• Ensuring the qualification of all facilities and utilities  areas as per Validation Schedule.
• Standardising validation approach ensuring consistency of application in accordance with agreed timelines and schedules.
• Ensure qualification of all equipment and validation  of  processes as per the equipment train and product portfolio.
• Ensuring the requalification and/or periodic reviews of all qualified equipment and utilities as per Validation Schedule.
• Comprehension of sterile manufacturing concept and associated processes such as the media fill, media hold, dirty and clean hold time studies.
• Determining test requirements and detection limits for validation samples to the Laboratory.
• Coordinating site calibration activities for all critical instruments and equipment.
• Samples Analyzed and report all non-conformances and failures.
• Providing recommendations and guidance on  changes related  to manufacturing process, equipment and  procedures.
• Performing cleaning validations and ensure that the cleaning validation matrix for all departments is maintained, protocols and reports are prepared in time.
• Proficiency in computerised system validation and application of relevant guidelines such as 21 CFR 11 Part 11, PIC/S Annex 11, GAMP 4, GAMP 5 etc.
• Compiling and updating departmental SOPs, protocols and reports.
• Proficient in the use of structured problem-solving tools and Quality Management System such as RCA (Root Cause Analysis), FMEA's (Failure Mode effects analysis), Change Control, Deviation, Corrective and Preventative Actions etc.  
• Proficiency in project management and use of relevant tracking tools.
• Managing budget, operating and capital expenses.  

Self-development

• Study new guidelines and policies from SAHPRA/PICS to keep abreast with developments and changes with regards to legal aspects and regulatory requirement pertaining to pharmaceutical, product manufacturing.
• Identify and communicate any skills/training requirements to help execute tasks efficiently.

Time Management and Self Discipline

• To ensure time keeping at all times
• To ensure that tasks allocated to individuals are performed and presented in time as scheduled

Requirements

• Degree within Natural Sciences or Engineering
• Minimum of 5 years in pharmaceutical validation experience of which 2 years must be as a Validation Manager.