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Senior Regulatory Compliance/Quality Assurance Specialist

Employer
i-Pharm Consulting
Location
London, England
Salary
Negotiable
Start date
6 Apr 2021
Closing date
20 Apr 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Job Details

Senior QA/RA Compliance Specialist

1.0 FTE

Negotiable pay rate

Home based - UK based applicants ONLY

Job Purpose (what is this job supposed to accomplish?)

To provide QA support for the manufacture of the Global Specialty pharmaceutical products commercialised within any affiliatein this Region in compliance with the registered regulatory information.

To assist the Company with a project to ensure that each product is currently being manufactured and supplied to the marketplace in compliance with the applicable Marketing Authorisations, national legal requirements and the corporate quality and regulatory standards.

Key Responsibilities: (what are the tasks, duties and responsibilities?)

  • To check the current finished product / raw material specifications, methods of manufacture, supplied artworks and analytical methods against the registered information and commitments made supporting the Marketing Authorisation for each product marketed in this Region including any current ongoing variations.
  • To positively confirm regulatory compliance for each product marketed in this Region and create a baseline document confirming that compliance.
  • To identify any gaps( and root cause of gaps to prevent reoccurrence) in each product's regulatory compliance, assess the impact of that gap and generate change controls, deviations and CAPAs to close that gap and return to a state of full compliance as quickly as possible.
  • To liaise with CMOs/Partners and Regional QA and Regulatory Affairs as necessary.

Position Requirements (knowledge, education, qualifications, number of years' experience, etc.)

  • A Life Science degree or equivalent preferably in pharmacy, process technology or advanced analytical science. Postgraduate training in regulatory affairs would be an asset.
  • Fluent in technical/pharmaceutical English (written & spoken) and another language (written and spoken) that is particularly relevant to that Region.
  • Experience or understanding of the registration and application process requirements (including managing variations) for pharmaceutical products, acquired specifically within regulatory affairs, quality assurance and quality control functions of a pharmaceutical manufacturer.
  • Familiarity with the structure, organisation and management of electronic CTDs.
  • At least basic knowledge of QC and/or manufacturing process technology for oral solid (non-sterile) and small volume parenteral (sterile / aseptic fill) products.
  • Familiarity with the pharmacopoeial requirements for pharmaceutical starting materials, finished products and packaging materials.
  • Around 6-8 years' experience of working within the Region's pharmaceutical industry including direct experience of working within a virtual pharmaceutical company, a manufacturing site and a research-based pharmaceutical organisation.

Key Competencies specific to the role (what traits or capabilities must they have in order to succeed, examples include presentation skills, attention to detail, capability to influence and negotiate)

  • Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution.
  • Interpersonal and technical communication skills
  • Excellent report writing and technical writing skills
  • Attention to detail and a painstaking approach to problem-solving
  • Organisation and documentation management
  • Cultural awareness and sensitivity
  • Intuitive and investigational / problem-solving skills
  • Familiarity with regulatory software, regulatory authority portals and Veeva® compliance software

If applicable to the role, outline the power granted or delegated to the role. For example power to release/recall products.

Initiation of change controls, deviations and CAPAs.

Project management and execution.

Creation of Product Regulatory Compliance Summary Documents.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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