Q&V Specialist - #144624

Key Roles/Responsibilities

JOB DESCRIPTION

• Provision of support and guidance to validation projects. This includes:
• Establishing project plans and milestones in conjunction with project teams in order to meet the customer’s needs.
• Facilitation of validation projects.
• Provision of validation expertise, advice and guidance to the project team to ensure compliance with site policy and procedures.
• Authoring of validation documents in conjunction with project teams and in compliance with relevant SOPs. The technical content of the documents is provided by the system owners and system experts.
• Facilitation of the review and approval of validation documents.
• Practical support during protocol execution where required and appropriate.
• Provision of practical support to Periodic Review activities.
• Maintenance of the SVMP Inventory and SVMP Schedule with information provided by the validation practitioners.
• Contribution to the development, implementation, maintenance and continuous improvement of validation policies, procedures, good practice example documents, templates and working practices.
• Generation of training packages and delivery of training on validation related topics.
• Maintain and develop knowledge of current regulatory expectations and industry best practices with respect to validation.
  
  

Key Competencies

• Attention to detail
• Thoroughness
• Planning and Prioritisation
• Good communication skills – written and verbal
• Problem solving
  
  

Qualifications

ESSENTIAL QUALIFICATION:

The holder will normally be expected to be qualified in a technical or scientific area which is relevant to the role. This may be through a formal educational / qualification route or via relevant experience and training obtained through practical application. It may also be a combination of both.

Relevant Experience

Technical knowledge of qualification and validation systems for which the holder has responsibility.

Relevant computer system skills

Communication skills – written (technical writing) and verbal

Presentation/ training skills

Planning and prioritizing.

Teamwork

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.