Summary
To maintain and develop the Dechra Skipton, GMP compliant, stability programme for veterinary medicines in compliance with VICH, FDA, and product licence requirements. You will provide technical and administrative input into the design, execution, trending and reporting of stability data. Other responsibilities of the role include: co-ordinating in-house/external stability testing capabilities/capacity and stability study control measures. Hands-on execution of analytical testing for stability samples is not within the scope of the role.
You shall enhance best practices and proactively contribute to a culture which is consistent with cGMP, cGLP and Health & Safety expectations within a pharmaceutical laboratory environment.
Stability management compliance activities to achieve key site and corporate objectives, within the Quality Control Department, ensuring Good Laboratory Practices are maintained throughout all Processes and Procedures.
Package
- Average 36-hour working week (with a day off every other Friday!!)
- Day shift - 8:00 - 16:30
- Plenty of training and development opportunities
- 22.5 days annual leave + Bank holidays
- Option to buy a week's holiday each year
- 8% Employer Pension Contribution
- Free access to the Headspace App
- Employee Assistance Programme
- Discounted gym membership
- Free on-site parking and electric charging
Main Responsibilities
So, what will you be doing?
-
To manage the routine and non-routine stability programs, including:
-
Writing the annual stability plan and report.
-
Monitoring the packing plan
-
Completing stability initiation forms to request samples
-
Preparing protocols and report templates
-
Label and set down samples
-
Ensure initial testing is performed within 1 month of setdown
-
To manage each timepoint during the study, including:
-
Pulling samples within the scheduled window and issuing the samples and required paperwork to the microbiology and chemistry laboratories
-
Send samples externally if required, obtaining quotes, completing test request forms and purchase requisitions
-
Review the testing plan to ensure all required testing is scheduled to be performed within the specified time period
-
Update records with the obtained results
-
Analyse trend data and investigate atypical or adverse trends.
-
Maintain the stability master data
-
Maintain stability chambers, including:
-
Manual top up of stability chambers with water
-
Download telemetry data, review and report on deviations from target conditions
-
Ensure the chambers are kept in good order. Samples from completed studies are disposed of, records of numbers of samples and their locations are accurately kept
-
Utilization levels are forecast to ensure capacity is available
-
Collate and report KPIs for tier meetings, QC management meetings and quarterly quality review meetings
-
Provide data and reports for internal and external customers including regulatory submissions and product quality summaries
-
Review data, protocols and reports prepared by peers.
-
Ensure all role relevant SOP updates are read prior to their effective date.
-
Write, review and revise SOPs, as required.
-
Perform Laboratory Investigation Reports (LIRs). Raise and actively manage Deviations, Change Controls, CAPAs, Due Date Extension Requests and Effectiveness Reviews for related work.
-
Manage escalation and communication of investigations and deviations
-
Play an active part in the development of the department by constructively highlighting deficiencies and inefficiencies and driving continuous improvement
-
Support peer development through coaching and mentoring.
-
Ensure ongoing training of all QC employees and staff in all departmental functions is scheduled, executed and documented in accordance with best practice.
-
Maintain knowledge of current regulations and guidelines
-
Comply with GMP and Health & Safety standards at all times.
-
In addition to the duties and responsibilities listed, the jobholder is required to perform other duties assigned by your Manager from time to time.
Ideal Candidate
- Highly computer literate with an attention to detail, (including formatting), and clarity.
- Effective and tailored oral and written communication skills, including writing of reports and deviations.
- Good time management and organisational skills
- Effective problem-solving abilities
- Effective prioritisation and decision-making skills
- Significant proven experience of analytical testing of finished product dosage forms, i.e. liquids, tablets, capsules.
- Working knowledge of ICH/VICH guidelines and regulatory factors impacting stability testing
Due to the nature of our business, all successful candidates will be required to complete a basic DBS check (Disclosure and Barring Service check) before employment can commence, and at regular intervals during employment. This check will be paid for by Dechra.