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Engineering, Environmental, Health & Safety
Quality, Compliance, Validation
Regulatory Affairs, Regulatory compliance
Staff, Legal, Public Affairs, Administrative
IT, Enterprise Applications & Systems
About the vacancy Engineering, Environmental, Health & Safety, Quality, Compliance, Validation, Regulatory Affairs, Regulatory compliance, Staff, Legal, Public Affairs, Administrative, IT, Enterprise Applications & Systems, Expert Bachelor’s Degree (HBO, WO) Permanent Full time 2440 Geel, Belgium
About Your Next Job Objectives and Responsibilities
Accountable for the Geel site internal audit program and external GMP inspection management (e.g. Health Authority, Customer).
Acting as compliance Subject Matter Expert and deploy compliance initiatives at the Geel site in alignment with the Pharmaceutical Regulatory Compliance strategy.
Coordinate team of Geel-based compliance personnel
Support the compliance teams of Beerse, Geel, Athens and Cork SM to deliver the site internal audit program and external GMP inspection management program.
About Your Tasks and Responsibilities Responsibilities IMRC Compliance Lead for Geel
Responsible for site internal audit program including:
Establish and create schedule
Auditor training (qualify and evaluate)
Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
Execute compliance walk-throughs (e.g. IWR)
Evaluate responses to internal audits
Enter internal audit data in Comet
Maintain site inspection readiness program for external GMP audits and inspections (Health Authority, Customer). Including:
Facilitate inspection management (front room, back room, coaching)
Lead the site response efforts including assignment of appropriate CAPAs
Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)
Partner with Quality to manage inspections (host and/or coordinate front room and back room, daily inspection summaries)
Review site response and associated CAPA for Health Authority inspections
Provide input to daily inspection summaries, as needed
Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices. Implement J&J Compliance Stds (e.g. Audit/Inspection Mgt) and partner with sites on J&J standard implementation
Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
Ensure appropriate and timely escalation of risks to the appropriate leadership and regulatory compliance teams. Facilitate remediation of compliance risks
Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance mtgs, etc.
Partner with site for execution of proactive compliance scans.
Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Mgt, etc.) to proactively identify risks and drive compliance improvement across the site.
Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices
As applicable, report progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.)
Collaborate with other groups in IMRC and JJRC to support execution of independent audits and special assessments. Support site during ERC audits (e.g. document review, front/back room support). Review and provide input to site response, and associated CAPA, to ERC audits.
Coordinate, maintain, report and drive site compliance metrics.
Establish department policy, standard operations procedures and working practices.
Coordinate compliance training for the site
Support Quality and Compliance strategy implementation
Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards
As needed, provide training for Quality concepts and/or systems.
As needed, co-authors, review and revise compliance procedures.
As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.
Partner with the site for execution of the site assessment as part of the SHARE program
Connect with site personnel in context of the compliance awareness (CARE) program
Environment, Health & Safety (EHS)
Always uses the appropriate prevention rules and procedures
Uses the available personal and collective protection materials correctly
Works neat and tidy
Reports (near) accidents, incidents, deviations and risky situations
Cooperates on and suggests solutions to improve safety, health an environment
Participate actively on promotion campaigns, working on the safe behaviour program, prevention controls
Addresses to other colleagues and third persons when prevention procedures are not followed or in case of unsafe behaviour
Credo
Takes into account the credo values in all daily activities
Integrates the Credo dialogue in the IMRC department
About Your Skills and Experience Profile needed for this function
At least 8 years related experience in a GMP-regulated industry and at least 3 years of regulatory compliance experience.
Extensive knowledge of global GMP regulations is required
Experience performing internal or external audits is required.
Ability to build partnerships and mediate issues while optimizing the value proposition.
Strong analytical skills and ability to clearly articulate issues.
Excellent communication skills, able to quickly build credibility within the Quality and Compliance community, and executive management.
Delivers on commitment timelines and has high sense of urgency.
Demonstrate business acumen, deal with complexity and ambiguity
Degree
Bachelor's Degree in Science or related field
Languages
Fluent in Dutch and English (written and spoken)
You are eligible to work in EU We only accept applicants who are eligible to work in the EU
#J-18808-Ljbffr
Quality, Compliance, Validation
Regulatory Affairs, Regulatory compliance
Staff, Legal, Public Affairs, Administrative
IT, Enterprise Applications & Systems
About the vacancy Engineering, Environmental, Health & Safety, Quality, Compliance, Validation, Regulatory Affairs, Regulatory compliance, Staff, Legal, Public Affairs, Administrative, IT, Enterprise Applications & Systems, Expert Bachelor’s Degree (HBO, WO) Permanent Full time 2440 Geel, Belgium
About Your Next Job Objectives and Responsibilities
Accountable for the Geel site internal audit program and external GMP inspection management (e.g. Health Authority, Customer).
Acting as compliance Subject Matter Expert and deploy compliance initiatives at the Geel site in alignment with the Pharmaceutical Regulatory Compliance strategy.
Coordinate team of Geel-based compliance personnel
Support the compliance teams of Beerse, Geel, Athens and Cork SM to deliver the site internal audit program and external GMP inspection management program.
About Your Tasks and Responsibilities Responsibilities IMRC Compliance Lead for Geel
Responsible for site internal audit program including:
Establish and create schedule
Auditor training (qualify and evaluate)
Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
Execute compliance walk-throughs (e.g. IWR)
Evaluate responses to internal audits
Enter internal audit data in Comet
Maintain site inspection readiness program for external GMP audits and inspections (Health Authority, Customer). Including:
Facilitate inspection management (front room, back room, coaching)
Lead the site response efforts including assignment of appropriate CAPAs
Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)
Partner with Quality to manage inspections (host and/or coordinate front room and back room, daily inspection summaries)
Review site response and associated CAPA for Health Authority inspections
Provide input to daily inspection summaries, as needed
Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices. Implement J&J Compliance Stds (e.g. Audit/Inspection Mgt) and partner with sites on J&J standard implementation
Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
Ensure appropriate and timely escalation of risks to the appropriate leadership and regulatory compliance teams. Facilitate remediation of compliance risks
Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance mtgs, etc.
Partner with site for execution of proactive compliance scans.
Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Mgt, etc.) to proactively identify risks and drive compliance improvement across the site.
Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices
As applicable, report progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.)
Collaborate with other groups in IMRC and JJRC to support execution of independent audits and special assessments. Support site during ERC audits (e.g. document review, front/back room support). Review and provide input to site response, and associated CAPA, to ERC audits.
Coordinate, maintain, report and drive site compliance metrics.
Establish department policy, standard operations procedures and working practices.
Coordinate compliance training for the site
Support Quality and Compliance strategy implementation
Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards
As needed, provide training for Quality concepts and/or systems.
As needed, co-authors, review and revise compliance procedures.
As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.
Partner with the site for execution of the site assessment as part of the SHARE program
Connect with site personnel in context of the compliance awareness (CARE) program
Environment, Health & Safety (EHS)
Always uses the appropriate prevention rules and procedures
Uses the available personal and collective protection materials correctly
Works neat and tidy
Reports (near) accidents, incidents, deviations and risky situations
Cooperates on and suggests solutions to improve safety, health an environment
Participate actively on promotion campaigns, working on the safe behaviour program, prevention controls
Addresses to other colleagues and third persons when prevention procedures are not followed or in case of unsafe behaviour
Credo
Takes into account the credo values in all daily activities
Integrates the Credo dialogue in the IMRC department
About Your Skills and Experience Profile needed for this function
At least 8 years related experience in a GMP-regulated industry and at least 3 years of regulatory compliance experience.
Extensive knowledge of global GMP regulations is required
Experience performing internal or external audits is required.
Ability to build partnerships and mediate issues while optimizing the value proposition.
Strong analytical skills and ability to clearly articulate issues.
Excellent communication skills, able to quickly build credibility within the Quality and Compliance community, and executive management.
Delivers on commitment timelines and has high sense of urgency.
Demonstrate business acumen, deal with complexity and ambiguity
Degree
Bachelor's Degree in Science or related field
Languages
Fluent in Dutch and English (written and spoken)
You are eligible to work in EU We only accept applicants who are eligible to work in the EU
#J-18808-Ljbffr