Lesly is back in action!!

lesly · Posted: Sun Aug 15, 2004 8:38 am Post subject: Lesly is back in action!!

Hi guys,

I know there are lots of newcomers since I last posted, it has been a while. Probably some of the 'seniors' remember me. The reason why I haven't been posting is because our house was for sale for almost a year now. Nobody seemed to be interested anymore, so we had actually almost given up hope. Guess what??? Today, a couple rings the bell, we open the door, and they buy the house. It was so unexpected, it's crazy!!!
We will probably be on our way to NZ in 4 months, no matter what happens with our EOI we submitted last week (the hope didn't completely disappear!) We have a modest score of 105 points so...??? Rolling Eyes

who knows, we hope to be picked out of the pool.
If not, we head for the adventure, and see what happens. It will be an adventure anyway, because our youngest son is disabled, and we still cannot find the answer to our question: 'do we even have a chance of obtaining PR with a child with special needs?' We did everything to find out, but we couldn't. We now rest our case.
Anyway, with a house being sold, we can now move on with our lives, and start buying tickets, selling some things we can't take with us to NZ, making arrangements for the quarantine,...

Thanks for reading my good news, it's great to be able to share it! We can't tell our family, they would get crazy, it would become a dramatic scene in a really bad soap opera! Nutcase

Like I said, I'm back in action, the real thing starts right now, so you will probably be hearing some more from me soon!! I'm sure there still are lots of questions to ask!

Cheers, Lesly Razz

Steven & Ann · Testing The Water Joined: 26 Apr 2004 Posts: 7

Lesly - really nice to hear from you again, especially with such brilliant news Clapping

. Just goes to show we should never give up hope cos things happen when we least expect it!! Wish you lots of luck with your packing up etc....think that's probably a saga in itself! Eek

Ann

karltsmith · Posted: Sun Aug 15, 2004 10:37 am Post subject:

Hey Lesly,

Great to have you back!!!! Nice One

The real estate market moves in mysterious ways Hmmm

How is your son?

Karl cool

abdul · I Like It Here Joined: 01 Dec 2003 Posts: 75

Hi Lesly

Welcome back . Its been a while since we heard from you
Great news to begin with and I happy for you.

All the best

Abdul

Azazel · I Like It Here Joined: 08 Jan 2004 Posts: 64

Congrats and good luck Nice One

lesly · Posted: Mon Aug 16, 2004 4:31 am Post subject:

Thanks to you all for the support, I'm really glad you guys remember me!
Hi Karl, I can see you made it to the top, being moderator on this forum!!! Nice One

I hope you're enjoying life in NZ.
My son is doing great, I am busy learning him how to read at the moment. It is not simple for a non-speaking person, he doesn't have the inner speech. Teachers at school failed last schoolyear, so I have decided
to try it myself, and it works, I just tried another method starting with 2-letterwords instead of 3. He's reading short sentences now!

I was (actually my husband was) wondering if it's hard for an analytical chemist to find a job in NZ. Since you are in the same field, maybe you should know. Confused

Thanks again and lots of luck to all of you Razz

Cheers, Lesly

karltsmith · Posted: Mon Aug 16, 2004 8:37 am Post subject:

Hi Lesly,

Grat news about your son1 It must be so rewarding to domit yourself and see the results before your eyes. I don't think it would be to difficult for your husband to secure a position. Depening o his background. I know of 10 positions to be filled for people with HPLC background!

Karl cool

lesly · Posted: Mon Aug 16, 2004 8:28 pm Post subject:

Thanks for the info, Karl. He has gained lots of experience , mostly in International Quality Control, in the past 16 years. It 's a relief to hear that it won't be impossible to find a job for an experienced person in that jobarea!
Cheers, Lesly Razz

karltsmith · Posted: Mon Aug 16, 2004 9:08 pm Post subject:

Hi Lesly,

Does your husband have a GMP,GLP or pharmaceautical background in additon to QC? I know of a company looking for a Regulatory Affairs Manager on the North Shore!

Karl Nice One

lesly · Posted: Mon Aug 16, 2004 10:12 pm Post subject:

Hi Karl,

I'm Lesly's husband (Michel). Nice to meet you. Many thanks for the help you already gave to us.
Replying to your question I give you a summary of my career (copy/paste from my cv) :

I worked 16 years at Janssen Pharmaceutica Belgium, a division of Johnson & Johnson. We manufacture mainly human drugs. Maybe you know the most popular drugs Imodium, Motilium, Nizoral, Prepulsid.
I worked initially (10 years) in the department of International Quality Control. We tested samples of Janssen Products manufactured by other J&J Companies, Contractors and Licensee holders (approx. 120 companies).
As the Laboratory supervisor I gained a lot of experience in following areas :
·QA/QC tasks typical for a Lab supervisor.
·Application of GMP, GLP, FDA rules, Part 11, Company Policies, Safety …
·How to manage a QC Lab :
o supervise analysts
o calibration, qualification of equipment
o validation of methods
o training of analysts
·using analytical techniques such as chromatography, UV, IR, titration, NMR, ...
·Other activities :
o method development and analytical troubleshooting in our lab and the labs of our affiliates,
o specification management,
o validation of analytical results,
o stock management,
o stability analysis,
o resource management of materials and people, ...
·I was the backup of the International QA/QC Manager. In his absence I approved Pharmaceutical Products for Release to the market.
·I had to support start ups of QC labs in our affiliates (e.g. Xian Janssen)
·Sharing and discussion of product quality information and points for improvement with QA Auditors.

In my current job (6 years) I’m the key user for our LIMS (Laboratory Information Management System) and our QMS (Quality Management System). Both systems are used by approx. 600 users.

In this job I gained experience in :

·The management and user support of these information systems (development/maintenance of SOP’s, training, management/control of changes, system administration regarding security) to keep them in line with departmental needs and GMP/FDA regulations.
QMS and ALIMS : for the processes of pharmaceutical intermediate products, pharmaceutical end products, chemical intermediate products, chemical end products, packaging materials and raw materials.

·The role of QA in signing Change Requests for criticality analysis, correct implementation.

·Use Citrix for access to software applications for remote users (India, France, Switzerland)
·Use Web-ex technology to give training to remote users
·Major software upgrades :
-Write and review documentation : User requirements, Validation Plan, Functional Specs, Test Plan, Test protocols for Operational and Performance Qualification, Test reports, Validation Summary Report, …
-Execute validation tests
-Train users
-Modify Procedures
·Evolution of these systems to Regional QA Systems :
-ALIMS and QMS are gradually being implemented in the other 5 sites of Pharma Europe.
-The supporting activities (write procedures, train people, software modifications, software validation, trouble shooting, …) for these systems in Europe, India and China require a good knowledge of written and spoken English. Additionally this requires good communication and coordination.
·Responsibility for a number of system administrative functions and for the user support of these quality information systems :
-development and maintenance of general procedures and work instructions to explain the users how to use the system in their area.
-organization of training and keeping of training logs
-management of user request forms and securities in the system
-first line support to the users when implementing changes and for problem solving
-definition of priorities for modifications (cost/benefit analysis)
-estimation of workload (programming an validation) for changes and follow up of Control of Changes (signing of the steps)
-keeping the validation file up to date
·The major challenge in this function is to assure that the widely used systems meet the requirements of each department regarding compliance, performance and user friendliness, without loss of benefits or functionalities for other departments using the system, taking into account the restrictions of technology and resources. The function requires a continuous weighing of contradictory importance such as :
-simplicity versus complexity
-satisfaction of the users versus restrictions of available resources.
-Expectations of the users versus resistance to changes (acceptation by users)
-Fast roll out versus gradual implementation of new systems or changes.

karltsmith · Posted: Tue Aug 17, 2004 8:41 am Post subject:

Hi Lesly,

This looks interesting, I know of at least 3 companies looking for senior personnel with this experience.

I'll PM you.

Karl

Tara Sage · Posted: Tue Aug 17, 2004 6:49 pm Post subject:

Hi Lesly

You probably haven't heard of me, but we arrived in NZ last month and just wanted to wish you luck.

Cheers

Tara Nice One

lesly · Posted: Tue Aug 17, 2004 10:24 pm Post subject:

Thanks Tara!! I certainly have heard of you. Yes

I hope you realise how lucky you are, and how many people would love to be in your shoes!!!

I wish you a great life in NZ Nice One

Cheers, Lesly

Tara Sage · Posted: Wed Aug 18, 2004 4:03 pm Post subject:

We know we are lucky, and Love being here Nice One

We had a relitively easy process so far, and hope that if there is anyone out there that needs any info I will do my best to help.

We are here on work visa's however I put in our eoi on Monday and have been selected this today Clapping

, so hopefullt PR here we come.

wiz · Posted: Wed Aug 18, 2004 4:13 pm Post subject: Selected awaiting PR

Hi Tara,

We were selected from the pool about three weeks ago - let me know how you get on!

I'm anxious to know a time-scale for processing (even if it's only a rough guide) If you get to know let me know and I'll do likewise. Nice One