Bulk,
Secondary & Biopharmaceutical Services
Our services for Bulk, Secondary and Biopharmaceutical
facilities include:
- Project Management and Co-Ordination
- Project Controls / Value Engineering
- Procurement
- Process Design
- Piping Design
- Civil/Structural Design
- Electrical/Automation
- HVAC/Building Services
- Validation / Regulatory Assistance
- Construction Management
- Contract Services/Client Management Teams
We also carry out the following speciality services:
Regulatory Specialists
DPS has a well established Validation Team which is trained and
has extensive experience in validating and assuring cGMP compliance
for Biopharmaceutical, Bulk and Secondary manufacturing facilities.
Validation assignments have been successfully completed for many
clients both as part of full design project management services
and as independent validation activities.
Our Validation Team is fully conversant with both FDA and European
Regulations and Standards as a result of working at various levels
in these regulated environments. Many of our projects have been
FDA approved and DPS has participated in the preparation of the
ISPE/FDA Baseline Guide for Design of Sterile Facilities.In addition
to our capability to undertake complete validation responsibility
for a new or existing facility, we can provide personnel to support
clients' validation teams or can handle specific segments of a
full validation project. Our capability covers the full range
of validation activities from initial planning through IQ, OQ
and PQ with our accumulated manufacturing experience being a significant
factor in PQ execution.
Technical/Process Specialists
DPS have recognised industry Process/Technical experts in the
areas of Air, Water, Cleaning, Filling (incl. lyophillization),
Fermentation, DSP (incl. chromatography), Containment/Isolation
Technologies, Clean Room layout and design for optimised personnel
flow requirements - to offer the most complete overarching technical
base to our clients Process/Technical assignments are carried
out for our clients both as part of full design project management
services and also as independent specialist activities/advisors
on individual assignments or as support team members in on-going
plant support activities. Our specialists are fully conversant
with current best practice in their areas of technical expertese
along with an understanding of client needs based on experience
gained in manufacturing companies. They can provide proactive
leadership in formulating effective problem remediation strategies
and also manage their execution for a client, passing on their
experience to key plant personnel in the process.
Commissioning/Start-up Specialists
DPS can provide renowned experts in Start-up/Commissioning of
a wide range of pharmaceutical facilities. This is a critical
activity in ensuring speed-to-market of products from new/modified
operating facilities which can be provided both as part of a full
design project management service or as an independent activity.
Our specialists understanding of client needs come from their
long pharmaceutical manufacturing background and this experience
forms the critical bridge between construction and validation
on complex projects of a greenfield or a retro-fit nature. This
team can undertake standalone assignments or integrate into an
existing client team to handle specific parts of an overall start-up
exercise to both FDA and local regulatory requirements. They can
provide proactive support or leadership in managing and executing
the commissioning/start-up of a facility.
Contract Services
The Contract Services Unit of DPS specialises in the recruitment
of suitably qualified professionals for short or long-term service
in the following disciplines:
- Process
- Project Management / Construction Management
- Regulatory and Validation
- Piping
- Instrumentation / Process Control
- HVAC
- Electrical
- Procurement / Cost Estimating / Scheduling
- IT Specialists
- Civil & Structura
- Document Control
- Safety Specialists
Our established reputation is based on providing clients with
a dedicated & professional service that offers genuine added
value across all disciplines.
- Specialised Recruitment Campaigns
DPS have the in-house expertise to manage every aspectof your
recruitment campaign, including:
- Advertising
- Pre-Screening
- Interviewing
- Short Listing through to the appointment of candidates
- Descriptions - Personnel Specifications
Our experienced personnel will produce specific job descriptions
and personnel specifications for all roles.
- Screening Candidates
When it comes to screening candidates, we can provide highly
trained interviewers and purpose designed facilities to ensure
proper screening of all potential employees.
- Head Hunting
DPS offer a full database facility for all disciplines which
can be used by clients to head hunt specific candidates.
- Safety Induction Courses
At your request we can implement safety induction courses and
certify candidates to Health & Safety standards.
- IT Consultancy
Temporary staff for:
- IT support
- Design
- Implementation
|