Posted on :
13 Dec, 2013
13 Dec, 2013
• Manage third party contract testing laboratories
• Manage testing schedule depending on business requirements
• Manage analytical issues e.g. OOS results and method queries, reference standards
• Manage analytical procedure changes
•Coordinate analytical method transfers as required
• Release bulk and final products for Pharmaceutical and Animal Health products.
•Evaluate records and testing results against registered specifications.
•Review batch records where applicable.
• Determine whether the product can be released for sale.
• Manage investigations and process deviations.
• Manage quality related issues i.e. follow up of inspection reports with third parties, assisting with and conducting QA audits, complaint management, certificates of analysis.
• Follow up on audit reports to close out findings
• Participate in audits with local or corporate auditors
• Conduct audits where applicable
• Manage and investigate complaints
• Prepare certificates of analysis where necessary for export products
Reporting Structure Reporting Structure:Affiliate Quality Operations Lead
Number of Direct reports: None
•Knowledge of the Pharmaceutical Industry and Healthcare environment
•Ability to analyse documentation and assess the relevance of process variances and reports on product quality.
Behavioural Skills and Attributes
•High levels of attention to detail with focus on quality is required in this position
•Planning and organising with key focus on achieving results is critical in this role in order to sustain a focus on performance and delivery of key objectives
•Decisiveness with the willingness to reach a conclusion and determine action
•Persistence to continue to attempt to achieve goals without being deterred by obstacles