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Job Details

QA Associate, UK compounding - 6 month

Company: Hobson Prior
Location: Oxfordshire
Reference: FCZQ1300
Closing Date: 12 Mar 18
Type: Contract
Salary (£): On Application
Benefits: Dependent on experience

Job Summary:

Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality. Responsible for release of product from the system. Responsible for supporting production in the review and post compounding check operations. Responsible for implementation and management of our client's quality system within the compound unit. Ensuring regulatory compliance. Ensure that unit is compliant with all corporate quality system policies and procedures

Requirements:

SUMMARY

Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality. Responsible for release of product from the system. Responsible for supporting production in the review and post compounding check operations. Responsible for implementation and management of our client's quality system within the compound unit. Ensuring regulatory compliance. Ensure that unit is compliant with all corporate quality system policies and procedures. Responsible for review of the implementation of the our client's Quality System to initiate, and drive continuous improvement

ESSENTIAL DUTIES AND RESPONSIBILITIES

- Post Compounding check and Release

Responsible for the Review of prescriptions on Merlin

Responsible for release activities associated with products manufactured at the compounding units.

- Change Control

Maintain a local change control process to ensure all changes are fully documented

Ensuring all changes are assessed for risk and impact prior to implementation

Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame

- Validation

Management of the site Validation Master Plan

Ensuring all equipment used for the manufacture and storage of product is validated before use

Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.

- GMP and Facilities and Equipment Control

Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.

Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete

Investigation of out of limits results using exception and CAPA processes

Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards

- Quality System Measurement and Review

Ensure outcomes, decisions and actions of the review are documented

Ensure meeting actions are completed to agreed deadlines

Track and trend on a monthly basis quality system data and indicators, including but not limited to

Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers

- Complaints

Ensures all incidents reported by customers are appropriately documented and investigated

Management of complaints using TW8

Responsible for reporting any complaints that may result in Field Corrective Action immediately to the

Business management representative and also the European FCA gatekeeper

Reporting any adverse events to Pharmacovigilance and the Business management representative

- Exceptions

Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated

Review and approval of exception reports

Leading and coordinating investigations in the cause of exceptions

- Corrective and Preventative Action

Monitor all quality system processes to detect need for improvements

Management of the CAPA system using Track wise software

CAPA owner and leader

Ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time frames

Raising supplier corrective actions to address out of specification raw material issues

Management of Supplier Corrective Action using Trackwise software

- Audit Management

Ensures that the facility is always ready for an internal,  corporate, MHRA or 3rd party audit

Manages the audit process for the facility, organization  of the management team and staff to ensure a successful audit

Ensuring that audit findings  are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue

- Communication and Training

Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance

Ensures staff understand their responsibilities under the quality system regulations

Communicates changes of the quality system to staff, ensuring appropriate training programs are executed.

- Document and Data Management

Ensures all procedures are controlled and current versions are available to staff as required

Ensures there are no unauthorized changes to documents including creation of local documentation.

Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.

Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible

Education                   

Science degree e.g. Pharmacy, Chemistry, Microbiology or equivalent

BTech- Pharmaceutical Science or equivalent work experience

English GCSE or equivalent

Experience

Breadth & Depth of experience

2 years experience of working in a aseptic compounding operation

12 months experience of quality system implementation

Field of expertise:
Ideally experience in all or any of the following:

Quality system management and implementation

Environmental /  microbiological control

Validation

Risk management

 If this role is of interest please apply by either using the form below or contacting me directly on 01892 612 612 or frankie.cunningham@hobsonprior.com

 

 

 

 

 

 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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