quality head SECTION
saja pharmaceutical
Total des années d'expérience :29 years, 10 Mois
1-Establish, review, update quality system as per (ISO 17025 &
GMP’s):
- Quality manual
- Documentation system
- Quality policy
- Standard operating procedures (operating, measuring, preventive maintenance)
- Quality formats
- Internal audit
- Customer complain
2- Corrective and Preventive Action system (CAPA)
3- Review all customer's final reports
4- Follow up all customers complains and insures from the right
corrective action.
5- internal audit system
6-Insure from the customer satisfaction and lab performance by
performing annual customer satisfaction survey and internal
audit.
7- SWOT analysis in order to measure the weakness, strengths, opportunity and threads.
8- Follow up employee’s performance in compatible with company quality policy.
9- Share with the top management in setting up and reviewing company policy
10- Share with the technical people in technical decisions
11- Share with the top management in creating new work job.
CONSULTATION:
1-VALIDATION CONSULTATION
2-GMPS, GLPS, GDP, GAmp CONSULTATION
3-Risk Assessment and Gap Analysis for (Food Industry,
Medical Industry, Pharmaceutical Industry, Drug Story
4- Trouble shouting solving
5- conceptual design
VALIDATION Department Establishing
a) Performing validation for the following machines with the
helpful of IMA/ITALY Company:
- VIAL WASHING MACHINE
- STERILIZATION TUNNEL
- VIAL FILLING MACHINE
- LABELING MACHINE
b) Performing validation for HVAC system with the helpful
of MRC/UK Company
c) Performing validation for IV solutions autoclave with
the helpful of PHASE/ITALY Company:
d) Master validation plan
e) Preventive maintenance program
f) Site master file
g) Cleaning validation
h) Computer Software
i) Change control system
j) Machine master file
k) Heat distribution & penetration study for autoclaves,
ovens, incubator & sterilization tunnel
2- CALIBRATION Department establishing
1- Responsible for preparation packaging material in house specification.
2- Responsible for packing in material supplier negotiation to select the right packaging material.
3- Responsible for packaging process steps design preparation.
4- Art work design (adobe illustrate) and flow this work with the raw packaging material suppliers.
5- Raw material in house testing.
6- packaging material supplier Auditing.
7- packaging process trouble shouting, investigation and problem solving
8- Barcode and pharma code design.
1- Prepare all protocols (IQ, OQ, PQ) for the following systems, equipment & instruments and performing protocols.
- UTILITIES (Water for injection, Purified water system, Pure
steam system, HVAC system, Oil free system, Industrial steam,
drainage system)
- PRODUCTION (Mixers, Oscillators, Blenders, Tableting
AND Coating machines )
- PACKAGING ( syrup line, Suspension line, tablet counting,
Blistering, labeling, cartooning, label counting machine )
- LAB INSTRUMENT (QUALITY CONTROL) (HPLC, Auto Titration,
Karl Fischer, Stability chambers, Atomic Absorption, TOC,
Balances)
- LAB INSTRUMENT (MICRO) ( laminar flow hood, Incubator,
Autoclave, Balances)
2- Master validation plan
3- Preventive maintenance System
4- Site Master file System
5- Cleaning validation System
6- Computer Software System
7- Change control system
8- Machine master file
8- Heat distribution & penetration study for autoclaves, ovens,
incubator
10- Machine master file system