QA Administrator en PCC-India-Information Technology
PCC-India-Information Technology · Morpeth, Reino Unido · Onsite
- Junior
- Oficina en Morpeth
Key Responsibilities:-
Administer and develop the following elements of the Pharmaceutical Quality System:
- Product Quality Reviews
- Technical/Quality Agreements
- Self-Inspection
- Customer Complaints
- Second-level Batch Record reviews
- Creation of Certificates of Conformity and Certificates of Analysis (including regulatory requests)
- Ordering of stationery and switchboard cover
- Preparation of documentation for EU release
- Validation / documentation store activities including pallet archiving / retrieving for all departments
- Update SOPs / FORMs, create new systems on a continuous improvement basis
- Collation of data for preparation of PQRs
- Document Control; the issuance and reconciliation of controlled documentation
- Ensure there are no overdue Quality System records that are attributable to your name.
- Support, as required, activities that relate to client audits and regulatory inspections.
- Keep abreast of and maintain systems in line with changing regulations and industry expectations.
- Constructively challenge deficiencies and inefficiencies.
- Identify and participate in continuous improvement initiatives within Quality.
Qualifications
ESSENTIAL QUALIFICATION:
None
RELEVANT/ESSENTIAL EXPERIENCE:-
‐An appreciation of GMP and GDP, such as the MHRA’s Orange and Green Guides, EU’s Eudralex Volume 4, USA’s CFRs 210 and 211, ISO, ICH, and PIC/S (desirable)
‐Administering elements of a Pharmaceutical Quality Management System (desirable)
‐High Level of Attention to detail
‐Excellent IT skills, proficient in Word / Excel
‐Organised and a good team player
About Company
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.
Company
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.
