Associate Quality Assurance Specialist

1 week ago

Loughborough, United Kingdom Kindeva Drug Delivery Careers Full time

Kindeva Drug Delivery is on a mission to solve drug delivery challenges and change patients’ lives worldwide, and we are able to achieve this due to our innovative, collaborative team. If you want to grow your CDMO career and be a force for good, you will have everything you need to excel at Kindeva.
With over a century of experience in combination product development and manufacturing, Kindeva is truly a global force in drug delivery. We have state of the art facilities across the US and UK and our capabilities span delivery formats, from ideation through commercialisation.
At Kindeva, we manufacture more tomorrows. Our products change and save lives across the world, and we are committed to developing meaningful and powerful solutions for our partners and the patients we serve. Every member of our team contributes to this mission, making a real difference, every day.

Ready to take on a career that matters? Look no further, we are hiring for a talented Associate Quality Assurance Specialist to join our Loughborough team.
Role overview
Auditing of manufacturing records for intermediates and finished products for batch release, development studies and customer complaints in line with the site procedures. Represent the department as required to include external customers and regulators. Other responsibilities are included with other tasks that may be deemed appropriate by supervision.
- Work in a safe manner taking responsibility for personal safety and the safety of others. Participate in safety initiatives within Group, e.g. APR,NM,MI, audits, etc...
- Actively raise APR's, NM's
- Follow the 10 rules of GMP- See Section iv.
- WorktoappropriateDocumentAssurancesystemsandprocedures, e.g.datarecording, labelling, investigation procedures. Maintain good housekeeping and follow Kindeva's 'clear desk' policy.
- Champion GMP standards and principles within the Document Assurance area.
- Maintain the documentation required for their personal EPR process, including training record.
- Able to train others in auditing of batch records, processes and systems having previously received training. Review and issue GMP documentation where full training has been received.
- Have an understanding of the site documentation and change control systems.
- Able to work positively as part of a team and communicate effectively with Group and peers. Able to effectively utilise written, electronic, verbal and other communication channels.

**What we will give to you**:
Attractive compensation package
Company pension scheme (up to 10% employer contribution)
25 days holiday per year (plus bank holidays) plus service days after 5 years
Company sick pay
Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family
Life assurance of four times life cover salary
Flexible working hours
Wellness programmes
Employee recognition program
Employee development
Free on-site parking
Discount and cashback at many retailers
Cycle to work scheme
Flu vaccinations
Employee referral scheme

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