Work was challenging and satisfying.
Two years in to my employment Company started to expend very rapidly.
Expenditure of the infrastructure, at the same time processing/pursuing
approval of many new products for US market and big legal problems with
brand name companies over ending patents and rights to ownership,
manufacture and market of some products effected directly and very
negatively internal situation within Company, making work unpleasant and on
daily bases hazardous. Company under immense pressure got in to problems on
all fronts and started to fight for its very survival. President of the
Company and Executive Group imposed strict confidentiality (documented) on
every thing what was going on with in Company.
On daily bases this situation/request created communication difficulties
(documented) among people and Departments.
Luck of communication and accountability created fertile environment for
many individuals rushing to take advantage of opportunities and engage in
unlawful activities and profiteering (documented).
Strict confidentiality leaded to purchases of process equipment which was
not designed to handle highly potent active ingredients (products).
It become routine, that by choice Company started to instate in position of
power individuals with out any pharmaceutical experience, with out basic
knowledge of principles governing functions with in pharmaceutical
Often individuals in charge of HR and production processes where arrogant,
ignorant, in conflict of interest and dangerous in their decisions/actions
Safety , GMP/SOP wasn't a priority any more (documented).
Chase after business, economical and legal issues was on the forefront.
For me and many other employees it becomes matter of survival to act with in
and try to reinforce compliance / enforcement of the Occupational Health and
Safety Act and its regulations (documented).
My former Employer was a work place with out Collective Agreement
Every time I raised IN OPEN MANNER safety, conflict of interest or product
quality issues individuals in charge of me (with participation of upper
management) did threaten, disrespect, intimidate, expose to active product
as punishment and at the end dismiss me in very unprofessional/deceiving
For 6.5 years I worked with active ingredients not protected by any safety
On regular bases I was requesting issuance of such protection and for so
long my requests where neglected (documented) . Once I was enrolled in
training session for respiratory protection, but I never had any hardware
New products were so potent that latex/rubber gloves where dissolving almost
on contact and product use to create horribly painful sores (documented).
Many operators worked with those products with out adequate protection and
often with out any at all (night shifts).
Process equipment was commissioned in Europe with out reviling recipe/
chemical composition of the product they suppose to process (documented) .
As result of it purchased equipment was received and installed, IQ
(Installation Qualification) was executed, but due to very potent nature of
the product OQ (Operational Qualification) was felling (documented). Every
thing what was not out of SS (Stainless Still) or glass the product was
dissolving in the process. Every attempt to produce experimental batches for
FDA (Food and Drug Administration) and batches to secure Launch Quantities
Every attempt to produce ended up with mechanical damage to the equipment,
contaminating Isolation Area and Operators. Shortly before Christmas time
2003 I was ordered by management (- that was direct order of Department's
Manager and Department's Director) to go and correct mechanical problems on
said equipment in isolation area (documented).
Damage occurred during production run on equipment which did not pass OQ
Every time butch of new products was processed, equipment was automatically
shutting down during process (destroying expensive batch) because electronic
safety system was detecting contamination of manufacturing area exposing
operators to the dangerous product.
This time in desperate attempt to produce quantities Company decided to
disable electronic safety / warning systems and despite contamination
produced few butches.
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