Job purpose (inclusive of, but not limited to)
To help assist and maintain the Quality Management System (QMS) in full compliance for the territory (UK);
To liaise with regulatory team, plant team, Quality Personnel and support to co-ordinate on batch 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 company and 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 department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
Preparing Monthly stock statements, identifying discrepancies with stocks and investigating 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 received from 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 Plant and QC laboratory), inclusive of completion of investigation co-ordination for any OOS/OOT related to the batch. This also includes sourcing requisites for the batches from plant for testing.
Co-ordination with the 3PL/4PL as required
Variations for MIA and WDA wherever necessary to be filed with relevant regulatory authorities.
Complete maintenance of QMS system online on secured platform provided by company
Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
Working with all members of staff to maintain and develop the positive progressive culture.
Qualifications
Scientific degree – (ideally pharmacy, pharmaceutical sciences, chemistry or related).
Essential Requirements:
Maintaining all official documentation with confidentiality and as per company 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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