QA Compliance Officer in Grangemouth

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 Officer

Job Description The 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 Gx P 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 Gx P 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- Power Point, 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.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries.

PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products.

In addition, one of PPL’s associate companies, Abb Vie Therapeutics India Private Limited is a JV with Abb Vie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area.

Further, PPL has a minority investment in Yapan Bio Private Limited.

In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment.

It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law.

Our employment decisions are based on merit considering qualifications, skills, performance, and achievements.

Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.

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