QC Team Leader (Technical Support)

Piramal Healthcare UK Limited; Grangemouth; On-site; GBP 45,000 - 65,000; Full time

Job summary

Piramal Pharma Solutions in Grangemouth, UK, seeks a QC Team Leader (Technical Support) to oversee the QC Equipment Team and coordinate release testing for materials and finished products.

You will serve as SME for analytical equipment and QC activities on client projects, ensuring SOPs and data integrity are followed, and driving continuous improvements within a GMP framework.

Qualifications

• SME for QC equipment and QC activities on client projects.
• Experience implementing and following SOPs and protocols.

Responsibilities

• Be the SME for analytical equipment aligned to client projects.
• Be the SME for QC activities aligned to client projects.
• Manage analytical procedures for testing materials and products.
• Ensure QC Analysts and QC Technicians are trained and competent.
• Escalate deviations to the QC Manager.
• Maintain clean, organized laboratories and readiness for inspections.
• Issue, manage and close-out deviations, change controls, OOS or CAPAs.
• Identify areas for continuous improvement and report to the QC Manager.
• Foster a collaborative team environment and support line manager requests.

Skills

QC Equipment SME

QC Activities SME

Job description

Be the First to Apply 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

QC Team Leader (Technical Support)

Job Description

Team Lead for the QC Equipment Team. To manage and co-ordinate Quality Control department equipment required for the release testing of raw materials, in process products, bulk drug substance, final products.

To be the point of contact for client projects, manage expectations and requirements and deliver against the SOP.

• Be the Subject Matter Expert (SME) for all Analytical Equipment aligned to client projects
• Be the Subject Matter Expert (SME) for all QC activities aligned to client projects
• Manage analytical procedures, for testing of raw materials, in process products, bulk drug substance, final products and stability products according to defined by SOP', and protocols and ensure that the QC team is in compliance with the same.
• Apply best cGMP work-practices and techniques to manage the testing and release raw materials, in process products, bulk drug substance, final products and stability products within specification and in accordance with Data Integrity requirements, Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data
• Ensure that all QC Analysts, QC Technicians are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times.
• Ensure subcontract of QC testing and dispatching to approved suppliers is performed according to defined procedures and in compliance with GMP.
• Manage on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the Senior QC Analysts and QC Analysts
• Immediately escalation and report any deviations to materials, facilities, processes or procedures to the QC Manager
• Be accountable for the analytical laboratories being clean, tidy and well organized and in a state of continuous inspection readiness.
• Conduct all activities in the most careful and safe manner and in full compliance with ESH requirements
• Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
• Issue, manage and close-out deviations, change controls, OOS or SST investigations and CAPA's in a timely fashion
• Identify areas for continuous improvement and elevate those to the QC Manager.
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
• To undertake any other duties as requested by the line manager in accordance with company requirements.

Company Information

Piralmal 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, PPL’s associate companies, AbbVie Therapeutics India Private Limited, a JV with AbbVie 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.