GDP/GMP QA Professional

Job Summary:

GDP/GMP QA Professional - End of year minimum contract - Competitive salary
Requirements:

Title: GDP/GMP QA Professional

Location: Berkshire

Basic purpose of the position
This role will provide Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) quality assurance (QA) for Client and other markets. The role holder will be expected to be proficient in a minimum of five of the following accountabilities. Within the team all responsibilities must be met by at least one team member.

Accountabilities

Plan, organise and control all own routine work to ensure that responsibilities are fulfilled in a timely manner.
To co-ordinate the activities of Third Party Logistics providers to the UK OPU to ensure that the regulatory requirements regarding GDP compliance are met.
To manage the Internal and External audit programmes and maintain Technical Agreements to ensure that processes and practices remain GDP-compliant.
To Support the Local Pharmaceutical Complaints Officer, (LPCO), in the processing of technical customer complaints through GCoMS and in the event of a product recall to ensure that regulatory, corporate and local requirements are met.
To co-ordinate the activities of the external contractor who provides analytical laboratory services, (Chemistry and Microbiology), and manage the requirements of Annual Product Reviews and Stability Reports to ensure regulatory requirements are met.
Support the management of the current GDMP documentation system and the GDMP archive to maintain the uniformity and compliance of our processes
To manage Corporate Standardisation Committee, (CSC), applications through corporate, (OCP 062), for the UK site to minimise delays in product introductions and changes.
To co-operate, support and share information with other team members and departments to maintain the efficient running of the GDMP department

Related Performance Indicators

Quality, cost and time targets are met and compliance with relevant SOPs and KPI targets is maintained.
Regulatory, corporate and local requirements are met
Audit programs are adhered to, Technical Agreements remain current.
Compliance with regulatory, corporate and local requirements for complaints and counterfeit management. Recall procedures related to the LPCO run smoothly and effectively.
Completion of the obligations related to UK-manufactured stability and customer complaints investigations, as well as Annual Report generation.
Effective control and quick recovery of documentation. (In the event of a recall within 3 hours).
Compliance with the corporate process and the facilitation of changes in product markets.
Information is freely available, tasks and projects are completed in good time, responsibilities and workload are evenly distributed throughout the team.

Interfaces (with other business functions or business units)

The role covers interactions with Corporate regulatory teams, SQE, International Logistics, and Medical.
This role covers interactions (audit, trouble shooting) with external suppliers and our contract acceptors.
Participation in the requirements of the corporate 'Delegation of supplier Audit' team
To support the incoming goods process, the returns process and the retention samples archive at licensed distributors. To support the RP in maintaining GDP internally and at our wholesale dealers.
GxP business partners - provide Client UK QA support for distribution activities (UK, Eire, Malta) to maintain our wholesale dealers' licences. This involves goods in, returns and retained samples.

Required Education & Knowledge

Degree level in a Life Science subject or equivalent in relevant experience
Direct experience in GDP and distribution management with externally certified training in GDP an advantage

Required Capabilities ( skills, experiences and additional competencies)
Skills & Experience

IT literate MS Office
Direct experience in pharmaceutical GDP and/or GMP at team leader or supervisory level with externally certified training in GDP an advantage.
Lead auditor certified or experience as support auditor.
Additional Competencies
Prioritise own workload on a daily basis

Entry (Minimum requirements for role holder at Entry)

Degree level in a Life Science subject or equivalent in relevant experience
Direct experience in GDP and distribution management with externally certified training in GDP an advantage
IT literate MS Office
Experience leading or supporting audits
Expected time from Entry to Trained and Performing Well: 12 - 18 months

NOTE: I am a senior recruiter within the industry across a number of job divisions for the pharmaceutical, biotech and CRO sectors. For a confidential and professional chat about your requirements/ career advice and the chance to register for free and receive weekly job updates, please call Alex on or email

If this role is not what you are looking for and you have experience in or are looking to enter the pharmaceutical, pharmacy, biochemical or other scientific fields, please still contact us anyway because listed here on BMJ are only a selection of the many vacancies we have available.

Keywords:

GDP/GMP QA Professional, QA Manager, IRCA,Microsoft project, Responsible Person, RP,Quality Assurance,
GDP/GMP QA Professional, QA Manager, IRCA,Microsoft project, Responsible Person, RP,Quality Assurance,GDP/GMP QA Professional, QA Manager, IRCA,Microsoft project, Responsible Person, RP,Quality Assurance

Read more: #.UcqyBZwuLFM#ixzz2XJQcHt9s
Pharma Jobs and News
Follow on Twitter | PharmiWeb on Facebook