Key Roles and Responsibilities
Performs laboratory analysis and schedules analysis for a QC team, within a large QC department, that provide DI complaint QC data to support GMP decision making across the Morpeth business, to agreed standards of safety, cGMP, cost and cycle times.
Responsibilities
* Support the QC Team Manager in the delivery of business commitments.
* Ensuring all materials/products are released in line with business requirements.
* Resolving, reviewing, and approving analytical laboratory investigations in a timely manner.
* Managing resource allocations to ensure customer demands are met through liaison with Supply Chain planners, Project Managers, or Technical Services Formulators.
* Maintaining QC OTIF in line with customer requirements – support "getting tablets to patients".
* Providing direct support to the QC Team Manager and deputising when required.
* Setting work schedules and priorities according to the resources allocated to the team and escalating any issues or concerns that may impact delivery of business commitments.
* Ensuring all GMP documents (SOPs/DOPs, methods, specifications, protocols, etc.) are understood and followed by the team; performing review and approval of all GMP documentation.
* Leading out-of-specification and safety investigations, ensuring investigations are appropriate, root cause identified, CAPA identified and implemented, and closures are in line with defined timelines.
* Managing the effective and timely close-out of QMS actions within the QC team, including Trackwise actions.
* Providing support to validation activities, including approval of protocols and reports for analytical methods, manufacturing processes, equipment and cleaning.
* Driving the team’s compliance with agreed metrics and collating data to support continual performance reviews.
* Supporting the execution and delivery of individual development plans for the team and highlighting training opportunities.
* Ensuring analysis is performed right‑first time, on time and in line with business requirements by trained and experienced analysts.
* Supporting the site’s monthly finance/sales plan, planning and prioritising the workload of the QC team to ensure delivery.
* Collecting and collating performance data.
Critical Tasks
* Ensuring analysis is performed right‑first time, on time and in line with business requirements.
* Setting work schedules and priorities according to the resources allocated to the team and escalating issues or concerns that may impact delivery.
* Collecting and collating data to facilitate management of performance, efficiency and utilisation of the QC team.
* Effective communication regarding QC activities within the business and to external customers.
Critical Skills
* Excellent planning and organisation skills – for self and others.
* Effective communication.
* Analytical technique expertise.
* Strong knowledge of cGMP requirements for QC laboratories.
* Good Manufacturing Practice (GMP).
Qualifications
* People management experience.
* Laboratory / technical expertise.
* Planning/multi‑tasking in a fast‑paced, changeable, compliance‑driven environment.
* Relevant experience in quality control, GMP, and QC documentation management.
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, colour, 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 and 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.
We also offer specialized services such as the development and manufacture of highly potent APIs, antibody‑drug conjugations, sterile fill/finish, peptide products, potent solid oral drug products and services for biologics like vaccines, gene therapies, and monoclonal antibodies.
PPS is supported by Piramal Pharma Limited’s investment in Yapan Bio Private Limited.
Job Details
* Seniority level: Mid‑Senior level
* Employment type: Full‑time
* Job function: Quality Assurance
* Industries: Pharmaceutical Manufacturing
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