Kindeva Drug Delivery
Our Work Matters:
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make:
You will work closely with Production, Quality Assurance, Quality Control, Engineering, Technical, Supply Chain and external customers or suppliers where required. The role is ideally suited to someone who enjoys problem-solving, technical writing, cross-functional working and driving issues through to robust, evidence-based conclusions.
Key Responsibilities include, but are not limited to:
- Lead product quality investigations, including deviations, OOS/OOT events, product defects, process issues and customer complaints, ensuring robust root cause analysis and effective CAPA implementation within the QMS.
- Own investigations from event identification through to closure, including containment, evidence gathering, product impact assessment, root cause analysis, CAPA definition, effectiveness checks and final investigation reports.
- Assess product and process risk, including potential impact to released or in-process product, repeat-event risk, batch disposition recommendations and escalation requirements.
- Coordinate cross-functional investigations, ensuring actions, responsibilities, timelines and investigation priorities are clearly communicated and progressed.
- Develop clear, technically sound and inspection-ready investigation reports that are traceable, scientifically justified and suitable for QA approval, customer response, audit and regulatory inspection.
- Maintain and actively contribute to the site’s excellent safety record by engaging in a safety-first approach.
Skills & Experience:
- Experience working in a manufacturing, pharmaceutical, medical device, engineering or similarly regulated environment.
- Minimum 2 years’ experience leading investigations into deviations, non-conformances, OOS/OOT events, customer complaints or product quality issues, with the ability to produce clear, evidence-based and audit-ready technical reports.
- Educated to degree level or equivalent in Manufacturing, Chemical Engineering, Pharmaceutical Engineering, Quality, Science or a related discipline.
- Good understanding of GMP, ISO 9001, quality management systems and regulated manufacturing expectations.
- Strong data interpretation and technical writing skills, with the ability to draw clear conclusions from manufacturing, laboratory, inspection and process data.
- Experience managing multiple investigations simultaneously while maintaining quality, compliance, timeline and stakeholder expectations.
- Computer literate and familiar with Microsoft Word and Excel.
- Knowledge of Lean, Six Sigma, Minitab or other continuous improvement and statistical analysis tools would be an advantage.
Key Capabilities:
- Strong problem-solving skills with the ability to remain objective, evidence-led and thorough when investigating complex issues.
- Confident communicator who can work effectively with production areas and cross-functional stakeholders.
- Good organisational, interpersonal and time management skills.
- Ability to prioritise competing investigations and drive actions through to completion.
- Confidence to challenge assumptions, incomplete evidence and unsupported conclusions in a professional way.
- Enthusiastic, flexible, conscientious and proactive in approach.
- Strong team player with the ability to work independently.
What we Offer:
- 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.
- Private Medical Insurance.
- 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.
Additional Information:
Working Hours: 37.5hrs per week (Onsite)
Location: Up Brooks, Clitheroe
All applicants must be eligible to work in the UK.
We believe our people make the difference at Kindeva, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide.
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Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Kindeva is an Equal Opportunity Employer
