Job Description

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

QA Compliance OfficerThe role of the QA Compliance Officer is to support governance and compliance of the Pharmaceutical Quality Management System (PQS) at Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications.
The role will support the site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have support key quality system elements and compliance improvements, working closely with relevant stakeholders on site.

Key Roles/Responsibilities:
• Supporting key quality system elements, including activities relating to QMS monitoring, Qualification of Vendors, Audits (Self-Inspections, Vendor Audits, Customer Audits).

• Support updates to regulatory agency registrations as applicable.

• Support tracking of site compliance commitments and follow up actions.

• Working with the wider site functions to drive down out of compliance events and implement quality improvements

• Support and track regulatory findings and trends that may lead into a focus of regulatory inspections

• Support review of procedures and other QMS related documentation according to internal guidelines and UK/EU/US/ICH and other region specific guidance.

• Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken.

• Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues.

• Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections.

• Escalate any significant breach of quality or regulatory compliance to Quality Management.

• Maintain productive working relationships with other site personnel and stakeholders.

Key Competencies:
• Attention to detail

• Problem solving skills

• Excellent communication skills

• Proficient in using Microsoft Office based applications- PowerPoint, MS Excel, MS Word, etc.

Essential Qualification:
College or Degree qualified in a related scientific, business, process/industrial engineering discipline.

Relevant Experience:

At least 2 years’ experience within Quality Assurance working to GMP.

Experience of performing self-inspections or audits of 3rd party suppliers (GMP material manufacturing /testing laboratories, API or Drug Product manufacturing facilities

Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations /Investigations /CAPA)

Certified Auditor Training

Experience working on activities associated with supplier/vendor/material approval

Experience of supporting activities relating to audits and/or regulatory inspections.