Do you have a good understanding of regulatory requirements within the pharmaceutical industry? We have an exciting role for a proactive and self-motivated Compliance Lead within our Quality Department in Queenborough, Kent.
You will leading a team which provides data to the operational teams to support management of Deviations, CAPA, Change Control, PQRs, Quality Technical Agreements, Self-Inspection programme, Complaints, Document Updates, Quality Rick Management and GMP Training.
• Ensure that the Queenborough facility maintains its compliance status by identifying areas for improvement and future challenges.
• Liaise with customers on compliance and regulatory matters. Provide the required information to the customers on time.
• Preparation, management and support for customer audits and regulatory inspections.
• Facilitate Quality and GMP training across the business.
• Collate data on Key Performance Indicators for periodic management review meetings, site metrics and customer business review meetings and prepare presentations.
Knowledge & Experience:
• Preferred honours degree in scientific discipline, or significant pharmaceutical and GMP experience.
• A comprehensive understanding of regulatory requirements e.g. FDA, MHRA, ICH is essential.
• Excellent written, communication and interpersonal skills are required. Must be proficient in the use of Microsoft Word, Excel and PowerPoint.
• Wide ranging experience of quality compliance across all business processes including production, laboratories and quality.
• Strong line management/leadership experience in a similar position within the pharmaceutical/life sciences sector.
• Strategic agility – provides clarity and focus on key priorities
What we offer
Above all, you can expect a safe, modern, friendly and collaborative working environment. We regularly benchmark ourselves against our industry and we are confident that we offer a competitive salary and benefits packages to all our colleagues including:
27 days plus statutory holidays
A defined contribution company pension scheme
Life assurance (equivalent to four times your salary)
All-employee share incentive scheme
Aesica is a leading pharmaceutical contract development and manufacturing organisation (CDMO) for developing both active pharmaceutical ingredient (API) and finished does forms.
Our state-of-the-art facilities are home to around 1,300 colleagues across six development, manufacturing and operational sites in the UK, Germany and Italy. We are particularly proud of the diverse workforce that we have built. It is this healthy mix of experienced pharmaceutical professionals and ambitious talent that helps us deliver on our business promises of expertise and innovation.
Our culture is driven by five core values.
Integrity > Respect > Team Work > Results Driven > Customer Focus
Integrity drives mutual Respect. Integrity and Respect are the basis for Team Work. Integrity, Respect and Team Work promote a Results Driven and Customer Focused culture.