Job purpose (inclusive of, but not limited to)
To help assist and maintain the Quality Management System [QMS] in full compliance for theterritory (UK);
To liaise with regulatory team, plant team, Quality Personnel and support to co-ordinate onbatch releases;
Duties and responsibilities
Complete co-ordination, documentation and assistance to Quality Personnel for maintaining the QMS (MIA, WDA & CD licences) and batch releases.
Observing and complying with GMP and GDP.
Author, review and approving the SOPs. Observing and complying with companyand quality Standard Operating Procedures (SOPs).
Preparing and reviewing of all Technical and Quality Agreements.
Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events. Mainly co-ordination with sales and PV team.
Helping/leading the regulatory audits, inspections, self - inspections as required.
Undertaking any other duties, either for this department or any other departmentwithin the business, which may be requested by the Line Manager, for which trainingand/or an explanation has been provided and understood.
Preparing Monthly stock statements, identifying discrepancies with stocks andinvestigating the same for resolution.
Stock sheets for CD substances to be maintained in isolation.
Preparing PQR [Product Quality review] documents with the help of PQRs receivedfrom the manufacturing plant and quality control laboratory.
CAPAs and Deviation logs to be maintained.
Yearly Mock-recalls to be performed.
New customer & supplier addition and verifications with regards to WDA and GDMP to be done monthly.
Liaising and coordinating for completion of AMT+MLTs (Analytical method transfer& verifications)
Complete co-ordination for Batch release documents to be performed (from Plantand QC laboratory), inclusive of completion of investigation co-ordination for anyOOS/OOT related to the batch. This also includes sourcing requisites for the batchesfrom plant for testing.
Co-ordination with the 3PL/4PL as required
Variations for MIA and WDA wherever necessary to be filed with relevant regulatoryauthorities.
Complete maintenance of QMS system online on secured platform provided bycompany
Ensuring good relations and communications with all members of the team andresponding politely and in a timely fashion to internal and external customers.
Working with all members of staff to maintain and develop the positive progressiveculture.
Qualifications
Scientific degree – (ideally pharmacy, pharmaceutical sciences,chemistry or related).
Maintaining all official documentation with confidentiality and as percompany policy.
Good understanding of the pharmaceutical market and quality aspects.
Credible and confident communicator (written and verbal) at all levels.
Strong analytical and problem-solving ability.
Hands-on approach, with a ‘can do’ attitude.
Highly Desirable:
* Good IT skills e.g. Microsoft Office (Word, Excel and Outlook)
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