Quality Executive (Technical Compliance)
Batch Review and Release of medicinal products listed on Aspire Pharma Limited's MIA and third party's MIAs.
Competitive Salary & Company Benefits | Home Based Role in India
Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients' lives across the world?
Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.
Do you want to be part of the journey? If so, here is your chance!
The Role
We are currently looking to recruit a Quality Executive (Technical Compliance) to provide full support for the Quality Assurance activities of the company in relation to Batch Review and Release of medicinal products listed on Aspire Pharma Limited's MIA and third party's MIAs.
What will you be doing?
As a Quality Executive (Technical Compliance) you will be responsible for a variety of different tasks including: -
• Batch documentation review, stability data checks, managing deviations / non-conformances, CAPAs, and change controls, and supporting MIA product setup, batch release, and documentation. Monthly compliance checks and launch activities are integral.
• Maintain awareness of current and new legislation/guidance for EU/UK GXP (GMP, GDP, GVP, GCP) in medicinal products, medical devices (ISO 9001, 13485, 14971), controlled drugs, nutritional products, and compliance with GDPR and the UK Data Protection Act.
• Ensure effective communication within Aspire Pharma and with vendors/customers to implement legislative changes, investigate non conformances/deviations, manage vendor performance, support timely product launches, maintain supply continuity, and update procedures as needed.
The Person
• Science Graduate
• 7-10 years' experience (desirable}
• Experience with MIA Batch Review (desirable}
• Experience working with Tracelink (desirable}
• Written and spoken English with good Communication Skills
• Time Management Skills
• Good Attention to Detail
• Proactive Team Player
• Proficient in MS Office (including, word, excel and outlook}
• Proficient in Adobe Acrobat and electronic signature (desirable}
• Proficient in Q Pulse or other electronic QMS (desirable}
Why join us?
• As well as a fantastic, inclusive company culture, where employees are truly valued and a competitive salary.
• Medical Insurance
• Learning and Development opportunities.
• Excellent opportunities for progression.
• Fantastic Company events and celebrations.
Department Role Locations
Quality - India
Home Based - India
About Aspire Pharma
Aspire Pharma supplies a range of pharmaceuticals and medical devices, both prescribed and over the counter (OTC). Our products are carefully selected to deliver value and differentiation to both patients and prescribers. Our focus is on extending Aspire's portfolio of innovative products in the UK and globally, for the long-term benefit of patients, partners and customers.
Founded in 2009
- Department
- Quality
- Role
- Quality - India
- Locations
- Home Based - India
- Remote status
- Fully Remote
About Aspire Pharma
Aspire Pharma supplies a range of pharmaceuticals and medical devices, both prescribed and over the counter (OTC). Our products are carefully selected to deliver value and differentiation to both patients and prescribers. Our focus is on extending Aspire's portfolio of innovative products in the UK and globally, for the long-term benefit of patients, partners and customers.
Quality Executive (Technical Compliance)
Batch Review and Release of medicinal products listed on Aspire Pharma Limited's MIA and third party's MIAs.
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