Our client, a leading international Pharmaceutical company is looking for and experienced and qualified Validations Manager at their head office in Aeroton in Johannesburg.

Job Purpose

To ensure that all validation systems including processes are qualified and validated to meet GMP requirements. To maintain all qualified and validated systems and to ensure that all controls are in place and adhered to. To properly manage departmental budget.

Required Learning

Degree / Diploma within Natural Sciences or Engineering preferred
Minimum of 3 to 5 years in Pharmaceutical validation experience of which 2 years must be as a Validation Manager.

Key Job Outputs

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

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

Qualifications and Validations

Draw up a Validation Master Plan (VMP) and keep it current Ensure qualification of all areas as per Validation Schedule.
Ensure qualification of all facilities as per Validation Schedule.
Ensure qualification of all equipment and validate production processes as per Validation Schedule.
Developing and determining validation criteria for new equipment/process or factory upgrades.
Ensure Validation of new systems and periodic revalidation of existing systems.
Determining test requirements and detection limits for validation samples to the Laboratory.
Ensure that Review and capturing all results on Calibrations; Area Qualification;
Samples Analyzed and report all non-conformances and failures.
Ensure Validation of all existing and new equipment as per Validation Schedule.
Recommend changes to manufacturing process, equipment or procedures to other Departmental Managers.
Perform cleaning validations and ensure that the cleaning validation matrix for all departments is maintained, protocols and reports are prepared in time. Performing risk analysis where required in place of or to supplement validation
Managing expenses to budget

New Products

Ensure Compilation of the Validation Report for all New Productions (3
Validation Batches) – monitor and evaluate changes:
1st Validation batch (capture all process amendments)
2nd Validation Batch (deviation to include all the process amendments of the 1st batch)
3rd Validation batch (deviation to include all the process amendments of the 1st batch)
At the end of the 3 batch validation review capture all changes via a change control request.
SOP’s and Guidelines
Ensure drawing up of new SOP’s or amend current SOP’s based on validation data.
Ensure all relevant SOP’s are updated.
Self-development
Study new guidelines and policies from MCC 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

Core Competencies

People management skills
Attention to detail
Verbal comprehension
Interpersonal awareness / empathy
Verbal and written communication skills
Teamwork
Planning and organising
Developing people
Presentation skills
Able to work under pressure
Writing protocols and reports Meeting timelines