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Senior Aseptic Specialist
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Engineering, Support
Projektbeschreibung
One of our clients, a multinational company in the pharmaceutical industry currently requires a Senior Aseptic Specialist
Start: ASAP
Length: min 12 months
Location: South of Brussels
Description:
* Benchmark bio and GMS sites to review best practice. To take part in conferences and workshops, to benchmark industry standards, build an external network
* Define global strategy for aseptic and EM practices eg EM locations, gowning, viable and non-viable monitoring program, material transfer, Grade A cont. capping, human behaviour, etc.
* Act as a reference for world class expertise in aseptic matters.
* Coaching global sites: Singapore, China, Belgium, France, USA, Canada
* Provide specialist support for major aseptic issues eg Contamination in Grade A/B areas, hidden surfaces, unusual aseptic issues, Media fill failures.
* Run aseptic transversal projects in the global sites network
* Global SME for aseptic and EM processes eg writing bio guidelines, defend global aseptic and EM issues in audits.
* Provide expertise regarding facility design and WOW for aseptic processes to senior management, Local QA, QC, GTS, GIO.
* Work/interact/partnership with GMS to standardize, harmonise and improve quality documents eg GQMPs
* Active member of the global community of practice eg discussion of technical aseptic issues, presentation of new concepts/improvements.
* Interpretation of regulatory documentation when they are updated.
Scope:
* >1500 headcounts working in aseptic processes indirectly managed
* 5 organizations directly impacted in 12 Bio Sites
* 3 organizations indirectly impacted in 12 Bio Sites + CMOs
* Oversee cross functional projects: for all aseptic manufacturing people and associated support (QA, QC, Validation, engineering in the production sites. Aseptic CMO eg Aseptic Training delivered to more than 1500 people (Belgium andglobal)
* Coaching of management of production building, and QA related on theShop floor
* Interfacing with GMS ASI (aseptic strategy & Intelligence)
Accountability Batch Records/Cost avoidance:
Cost Of Poor Quality (COPQ) impact on release/costavoidance for aseptic matters: > 50 Mo Euros/year
Knowledge:
* Bachelor's Degree
* min. 10 years practical experience in aseptic manufacturing
* Microbiology, bio-engineering, pharmacy, biology, food industry
* Complexity and specificity of aseptic vaccine manufacturing
- Post-graduate degree (Master, PhD, DSc ) + practical experience in aseptic manufacturing or quality role
- Microbiology, bio-engineering, pharmacy, biology
Job-Related Experience:
- Strong and demonstrated experience in aseptic manufacturing is a must.
- Experience in quality assurance, quality control (microbiology),engineering, regulatory inspection, project support is preferred.
- Credibility. Complexity and specificity of integration of aseptic aspects in vaccine manufacturing
Background:
* Use of OE tool (eg Green belt certified )
* Excellent communication skills in English (oral and written)
* In depth knowledge of international regulation for aseptic vaccine production
* Networking and influencing skills
Application:
* In-depth knowledge of aseptic and EM processes which is used toidentify risk in aseptic processes.
* In-depth knowledge of GMP and this can be interpreted to the globallevel (eg written guidance or GQ(M)P, rational, mitigation solution,technical reports, position papers)
Nature of Interaction:
* Strong influencing skills across all levels (shop floor tosenior management)
* Good ability to coach and mentor (production and QA management, and aseptic operators).
* Coaching, mentoring of site SMEs
* Negotiation with Corporate Aseptic team to make the Vaccines particularities be integrated in the GQ(M)P
* Interactions with Regulatory Intelligence to review Authoritiesnew Guidance in draft
The interactions described behind are worldwide: one representative persite.
- Multi-lingual team
- Influencing all sterile sites and sterile CMO.
- Deal with specific approach for China, India, Emerging markets (egto adapt specific training package)
Tags: aseptic, aseptique, GMP, Risk Assessment, pharmaceutical, pharmaceutique
Start: ASAP
Length: min 12 months
Location: South of Brussels
Description:
* Benchmark bio and GMS sites to review best practice. To take part in conferences and workshops, to benchmark industry standards, build an external network
* Define global strategy for aseptic and EM practices eg EM locations, gowning, viable and non-viable monitoring program, material transfer, Grade A cont. capping, human behaviour, etc.
* Act as a reference for world class expertise in aseptic matters.
* Coaching global sites: Singapore, China, Belgium, France, USA, Canada
* Provide specialist support for major aseptic issues eg Contamination in Grade A/B areas, hidden surfaces, unusual aseptic issues, Media fill failures.
* Run aseptic transversal projects in the global sites network
* Global SME for aseptic and EM processes eg writing bio guidelines, defend global aseptic and EM issues in audits.
* Provide expertise regarding facility design and WOW for aseptic processes to senior management, Local QA, QC, GTS, GIO.
* Work/interact/partnership with GMS to standardize, harmonise and improve quality documents eg GQMPs
* Active member of the global community of practice eg discussion of technical aseptic issues, presentation of new concepts/improvements.
* Interpretation of regulatory documentation when they are updated.
Scope:
* >1500 headcounts working in aseptic processes indirectly managed
* 5 organizations directly impacted in 12 Bio Sites
* 3 organizations indirectly impacted in 12 Bio Sites + CMOs
* Oversee cross functional projects: for all aseptic manufacturing people and associated support (QA, QC, Validation, engineering in the production sites. Aseptic CMO eg Aseptic Training delivered to more than 1500 people (Belgium andglobal)
* Coaching of management of production building, and QA related on theShop floor
* Interfacing with GMS ASI (aseptic strategy & Intelligence)
Accountability Batch Records/Cost avoidance:
Cost Of Poor Quality (COPQ) impact on release/costavoidance for aseptic matters: > 50 Mo Euros/year
Knowledge:
* Bachelor's Degree
* min. 10 years practical experience in aseptic manufacturing
* Microbiology, bio-engineering, pharmacy, biology, food industry
* Complexity and specificity of aseptic vaccine manufacturing
- Post-graduate degree (Master, PhD, DSc ) + practical experience in aseptic manufacturing or quality role
- Microbiology, bio-engineering, pharmacy, biology
Job-Related Experience:
- Strong and demonstrated experience in aseptic manufacturing is a must.
- Experience in quality assurance, quality control (microbiology),engineering, regulatory inspection, project support is preferred.
- Credibility. Complexity and specificity of integration of aseptic aspects in vaccine manufacturing
Background:
* Use of OE tool (eg Green belt certified )
* Excellent communication skills in English (oral and written)
* In depth knowledge of international regulation for aseptic vaccine production
* Networking and influencing skills
Application:
* In-depth knowledge of aseptic and EM processes which is used toidentify risk in aseptic processes.
* In-depth knowledge of GMP and this can be interpreted to the globallevel (eg written guidance or GQ(M)P, rational, mitigation solution,technical reports, position papers)
Nature of Interaction:
* Strong influencing skills across all levels (shop floor tosenior management)
* Good ability to coach and mentor (production and QA management, and aseptic operators).
* Coaching, mentoring of site SMEs
* Negotiation with Corporate Aseptic team to make the Vaccines particularities be integrated in the GQ(M)P
* Interactions with Regulatory Intelligence to review Authoritiesnew Guidance in draft
The interactions described behind are worldwide: one representative persite.
- Multi-lingual team
- Influencing all sterile sites and sterile CMO.
- Deal with specific approach for China, India, Emerging markets (egto adapt specific training package)
Tags: aseptic, aseptique, GMP, Risk Assessment, pharmaceutical, pharmaceutique
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges