QA/ Quality Assurance Lead, Pharmaceuticals

Description:

QA/ Quality Assurance Lead, Pharmaceuticals
Location: Bolton/ North Manchester area
Type: Permanent
Salary: £30,000 - £33,000 depending on experience
Hours: Days (Monday - Friday),varied pattern depending on business needs; between 9am-7pm
Additional: Annual performance bonus, health assured and company ran incentives

Our Client a Pharmaceutical company (part of a large Pharmaceutical group) is looking to strengthen their QA team. This role has 4 reports / responsible for management of these team members.

• Support in QMS activities where required.
• Initiate, manage and supervise the process of generation and review of SOPs and other quality related documentation.
• Supervise and maintain temperature and humidity monitoring system and building environmental system.
• Manage the internal audit programme to ensure continued GMDP compliance of site wide activities.
• To ensure internal audit schedule is followed as per procedure and ensure follow up.
• Be responsible for the document control system ensuring issue and archive as per procedure.
• Provide technical expertise to support the customers and answer queries including those related to product investigations.
• Control customer enquiries and product licensing projects.
• Manage and maintain the supplier approval process including the approved supplier list.
• Liaise with suppliers in order to obtain documents needed for Quality Approval.
• Generate supplier audit documentation and technical agreements.
• Support in preparation of external audits and MHRA inspection.
• Ensure timely in-process and stock batch release.
• Govern the system of technical agreements and non-disclosure agreements.
• Supervise Health and Safety tasks within department.
• Liaise with regulatory authorities (MHRA & HPRA) relating to quality and compliance matters.
• Support and manage to resolve customer complaints, recalls, change controls, etc. ensuring proper root cause analysis, prompt responses/resolution.
• Assist in training and education of QA and other teams as advised by the line manager.
• Coordinate and resolve customer complaints ensuring prompt responses, investigation, resolution and feedback.
• Review and approval of new batch manufacturing record and update of record.
• Contribute in document control system including reporting and recording deviations, errors, fails, noncompliance and other quality forms.
• Participate and assist in the process of generation and review of SOPs and other quality related documentation.
• Coordinate the requirements for imported products from EU and non-EU states.
• Participate in training activities and maintain personal training records in an auditable state.
• Utilise scientific sources and interact with all departments in order to work on improving quality of products and services.

The Person:

• Good knowledge of GMP related pharmaceutical manufacturing
• 3 years GMP experience in a similar role
• Demonstrated compliance with procedures and policies
• Excellent team, interpersonal skills, and communication skills (both written and verbal)
• Ability to interact successfully with multicultural members of staff
• Willingness to work flexible hours
• Safe adoption of working practises together with an understanding of the needs for precise and accurate documentation

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us