Quality Assurance Officer (Pharmaceutical Manufacturing)
- Recruiter
- Anonymous
- Location
- Cramlington
- Salary
- Benefits
- Posted
- 09 Dec 2018
- Closes
- 10 Dec 2018
- Sectors
- Manufacturing & Industrial
- Contract Type
- Permanent
- Hours
- Full Time
COMPANY DESCRIPTION, PROFILE AND SCOPE OF ROLE:
Our Client is a well-established Pharmaceutical/manufacturing business and world leader in their field.
This role represents an excellent career opportunity for an experienced QA Officer with Batch release experience,
to perform batch sentencing activities on a named set of products and all quality assurance activities, (reviews/approvals/audits etc.) relating to those products and specific plant/business areas, as well as maintaining operational quality systems covering specific areas of expertise, and to perform work in accordance with cGMP and regulatory standards.
The successful candidate will report directly to Head of Quality but is expected to determine own day-to-day priorities and be proactive in identifying key issues for attention.
KEY DUTIES & RESPONSIBILITIES:
* As a SAP user the job holder will be required to carry out assigned SAP transactions in an accurate and timely manner.
* Sentence all controlled intermediates and finished goods in an agreed timeframe, in accordance with written procedures. These cover production and analytical review, deviation and change assessment.
* Responsible for all OQ approvals of PRSs, changes (process, analytical and engineering procedures) which relate to specific products to ensure they are carried out in accordance with relevant product registrations.
* Perform OQ assessment of all 'Decision Paths', non-conformances and deviations (including out of calibration).
* Review all cGMP cleanouts and ensure manufacture is not commenced prior to completion of a satisfactory cleanout.
* Ensure that specific product set and specific plant/business areas are cGMP compliant through audit, review and monitoring. Identify relevant corrective actions and ensure they are closed out through QATs.
* Maintain OQ systems covering change control
* Approval of master PRS's and procedures
* Handle complaints, audit observations and customer notifications and co-ordinate annual reviews.
* Responsible for co-ordinating validation activities.
* May have responsibility for co-ordinating Document Reviewer activities
QUALIFICATIONS, EXPERIENCE, SKILLS AND ATTRIBUTES:
* Degree or equivalent in a scientific discipline.
* Auditing principles and practices with recognised certificate.
* Excellent skills in communication and the writing of SOPs and reports.
* Comply with all HSE requirements including safety policies and procedures
* Experience in Active Pharmaceutical Ingredient or Pharmaceutical Industries, in quality assurance
* Comprehensive knowledge of all cGMP requirements/guidelines applicable to API manufacture
* API quality assurance, laboratory practices and production
Our Client is a well-established Pharmaceutical/manufacturing business and world leader in their field.
This role represents an excellent career opportunity for an experienced QA Officer with Batch release experience,
to perform batch sentencing activities on a named set of products and all quality assurance activities, (reviews/approvals/audits etc.) relating to those products and specific plant/business areas, as well as maintaining operational quality systems covering specific areas of expertise, and to perform work in accordance with cGMP and regulatory standards.
The successful candidate will report directly to Head of Quality but is expected to determine own day-to-day priorities and be proactive in identifying key issues for attention.
KEY DUTIES & RESPONSIBILITIES:
* As a SAP user the job holder will be required to carry out assigned SAP transactions in an accurate and timely manner.
* Sentence all controlled intermediates and finished goods in an agreed timeframe, in accordance with written procedures. These cover production and analytical review, deviation and change assessment.
* Responsible for all OQ approvals of PRSs, changes (process, analytical and engineering procedures) which relate to specific products to ensure they are carried out in accordance with relevant product registrations.
* Perform OQ assessment of all 'Decision Paths', non-conformances and deviations (including out of calibration).
* Review all cGMP cleanouts and ensure manufacture is not commenced prior to completion of a satisfactory cleanout.
* Ensure that specific product set and specific plant/business areas are cGMP compliant through audit, review and monitoring. Identify relevant corrective actions and ensure they are closed out through QATs.
* Maintain OQ systems covering change control
* Approval of master PRS's and procedures
* Handle complaints, audit observations and customer notifications and co-ordinate annual reviews.
* Responsible for co-ordinating validation activities.
* May have responsibility for co-ordinating Document Reviewer activities
QUALIFICATIONS, EXPERIENCE, SKILLS AND ATTRIBUTES:
* Degree or equivalent in a scientific discipline.
* Auditing principles and practices with recognised certificate.
* Excellent skills in communication and the writing of SOPs and reports.
* Comply with all HSE requirements including safety policies and procedures
* Experience in Active Pharmaceutical Ingredient or Pharmaceutical Industries, in quality assurance
* Comprehensive knowledge of all cGMP requirements/guidelines applicable to API manufacture
* API quality assurance, laboratory practices and production