To ensure that the quality system's design, implementation and execution are compliant with applicable GMP regulations across the Melville site. Provide key support role to the Site QA Leader. Be familiar with applicable GMP Regulations, Guidelines and Good Practices. Lead the site in key compliance activities and responsibilities, as described below. Be a source of expertise for the site in understanding GMP Regulations, implementing them in a practical way, maintaining and improving compliance and facilitating successful site audits by Regulatory Agencies. 20% Maintain a thorough knowledge and understanding of applicable GMP Regulations, Regulatory Agency Guidelines, Industry Association Guidelines, and Good Practices. Lead the practical interpretation and implementation of Regulations, Guidelines and Good Practices, to ensure that all site activities are compliant. Ensure that documentation and records are compliant 20% Lead the site in developing and implementing quality systems across the full scope of Regulations, Guidelines and Good Practices 15% Ensure QA oversight is in place across the full life cycle of regulated products - new launches have been appropriately signed-off before placing on the market, process validation is complete, change control is in place and relevant products are annually reviewed 15 % Lead the implementation across the site of a self audit program. Play a leading role in any visit, audit or contact with Regulatory Agencies. Ensure that site training program drives compliance to GMP. 10% Ensure that the site implements corrective and preventive investigations and action plans in response to all incidents and audits, in a timely manner 10% Work with other sites to ensure that good practices are shared and reapplied, consult with other QA organizations, for example Canada, Northtec and NA Contract Manufacturers to guide and assist them in GMP Compliance activities 10% Lead the investigation at the site of consumer comments in a timely manner to maintain compliance with relevant regulations
Bachelor's Degree or Post Graduate Degree in a Technical Field such as Engineering, Chemical Engineering or Microbiology Minimum 10 years related experience Occassional travel to seminars, courses and other sites. "Knowledge of GMP regulations and proven experience of developing and implementing quality systems in regulated industry. Experience of dealing with Regulatory Agencies. Ability to communicate at all levels so that they fully understand the requirements of Good Manufacturing Practices. Be persuasive and gain the support of the whole organization to implement, maintain and continuously improve quality systems. Be rigorous in following up action plans "