Quality Compliance Specialist

cap LP & Associates' client

post time Posted 60 months ago

Quality Compliance Specialist

Description:

1. Contribute to the establishment, continuous improvement and maintenance of the QMS at BOPU by ensuring that all external (e.g. GMP, GDP) and internal COMPANY requirements (e.g. Policies, OCS, OCP, ACP) are implemented, monitored for performance/adherence and improved, if required.

2. Responsible for setting and driving a Quality and Compliance Strategy for the BOPU together with the respective BOPU Management.

3. Ensuring appropriate Quality oversight related to GMP and GDP in the BOPU by:

• Managing external service providers (re-packagers – secondary packaging, distributors, freight forwarders, warehouses, graphic offices, contract laboratories, Co-promotion/Co-Marketing partners, Out-licensing partners and all other outsourced services with GMP/GDP relevance) in all quality relevant aspects during the life cycle of a contract, beginning with the issuance until termination, to ensure local supply and manufacture of products or services with acceptable quality, in full regulatory compliance and in accordance with contractual obligations and COMPANY guidelines.

• Implementing/revising relevant GMP/GDP quality systems related to commercial product supply in the country to meet the continual needs of the company and the local authorities and ensure that products and processes/systems are delivered to the customers with a consistent high quality standard and in accordance with COMPANY requirements and the local legislations.

Note: Some of the tasks may be delegated to other people within BOPU or other quality functions in the ROPU, however, final accountaCompanylity remains with the QCO.

• Ensure knowledge management within the BOPU by acting as interlink to ROPU Quality Compliance Officer (QCO), centralizing expertise, best practice sharing and training within the BOPU.

• Ensure efficient implementation of standards within the BOPU by maintaining a common document management system, implementation of OCS, OCPs, and further Corporate documents, and applicable ROPU processes, monitor the roll out and standardization of processes.

• Ensure continual quality and compliance improvement within the BOPU by coordinating Quality target setting, identifying optimization potentials, monitoring the BOPU performance via self -inspection/self-assessment program and by consolidating the BOPU quality update for ROPU Quality Management Reviews.

• Solid reporting line to Head of Finance & Administration, functional reporting to ROPU SEASK Head of Quality Compliance.

Duties & ResponsiCompanylities:

1. STRATEGIC:

1.1. The job holder is responsible the tactical translation and execution of the Quality and Quality Compliance strategy at the BOPU, which includes:

- Ensuring all external (GMP, GDP) and internal COMPANY requirements (Policies, OCS, OCP, and, ACP) are implemented

- Monitoring and improving performance adherence

- Ensuring appropriate Quality oversight.

DRIVING BUSINESS RESULTS/PROCESS/CROSS-FUNCTIONAL COLLABORATION:

2.1 The job holder is responsible for the External Service Provider Management, which includes:

- Ensuring GMP/GDP and regulatory compliance of products/services which are outsourced to external parties

- Operating/acting in the capacity of a key quality contact for assigned suppliers/external partners (including QAA negotiation and maintenance, audit management, complaints processing, assessment of deviations, CAPA management, change control, vendor rating and project support), establishing and maintaining effective quality systems and procedures in accordance with COMPANY requirements

- Establishing and maintaining contact to relevant quality management with suppliers/external partners, ensuring seamless and proactive communication and collaboration and align processes between COMPANY and supplier/external partner

- Supporting GMP/GDP audits at local suppliers and external partners (qualification and regular audit), supporting the annual audit plan and follow-up on CAPAs resulting from audit findings

- Ensuring and/or trigger a cross-functional alignment among the COMPANY stakeholders (e.g. Business, Legal, SCM, etc.) and with the assigned external partners to safeguard and control all processes required for supplying to/receiving products/services from external partners in terms of quality and compliance during the overall contract life cycle. Perform regular vendor rating

- Act as first escalation to resolve quality issues including possible counterfeits with external partners and at COMPANY/external partner interface. When necessary, escalate issues within COMPANY to resolve conflicts promptly and minimize risk to COMPANY

- Negotiates quality relevant issues in contracts or QAAs, ensure regular review of QAAs and revise if necessary, monitor overall contract compliance in respect to quality aspects.

2.2 The BOPU QCO is responsible for internally managing the Quality System Management – Documentation Management, which includes:

- Ensuring the set up and maintenance of a document management system for local SOPs/Working Instructions (archiving, distribution, access, revision)

- Ensuring that applicable Corporate Procedures are transferred into local SOPs/Working Instructions

- Ensuring that training on SOPs/Working Instructions is properly performed and documented

- Analyze any significant changes in the GMP/GDP environment and identify need for SOP/Working Instructions writing and/or communication to ROPU QCO on any local Regulatory changes.

- Write SOPs/Working Instructions or approve SOPs/Working Instructions.

2.3. The BOPU QCO is responsible for internally managing the Quality System Management – Operations Regulatory Intelligence (ORI), which includes:

- Maintaining a library of all the relevant regulations and guidelines related to commercial product supply and distribution such as GMP, GDP and if applicable local regulations regarding cosmetics, food supplements or medical devices.

2.4. The BOPU QCO is responsible for internally managing the Quality System Management – Audit Management, which includes:

- Ensuring regular self-inspections at the BOPU to drive the continuous improvement program and to ensure readiness of the BOPU for Corporate or Authority inspections

- Managing audits by Corporate or inspections by local Authorities in respect to GMP/GDP

- Ensuring adequate CAPA plans are established and tracked for completion.

2.5. The BOPU QCO is responsible for training, which includes:

- Identifying training needs at the BOPU and coordinating/performing all facets of GMP/GDP training (introduction and ongoing) inclusive buildup of Quality Culture within the organization.

.6. The BOPU QCO is responsible for Product Supply Support, which includes:

- Ensuring that all necessary permits, authorizations, QAAs or QSLAs to manufacture, repackage and/or import/ export, distribute products are available

- Batch disposition (release/reject) for distribution if applicable as per local regulations

- Provide Launch support (e.g. coordinate local repackaging)

- Ensuring correct handling and storage of market returns, promotional and retention/reserve samples

2.7. The BOPU QCO is responsible for Project Support, which includes:

- Representing QCO on project teams

2.8. The BOPU QCO is responsible for Quality oversight, which includes:

- Performing all related duties assigned to the Marketing Authorization Holder for distribution of product in the market

- Leading/Supporting the Quality Management Review (QMR) of SEASK

- Establishing and maintaining a Quality Manual which describes the QMS of BOPU (if applicable)

- Aligning with other key functions in BOPU for continuous improvement of the QMS

- Representing quality function in the local management team (if applicable)

- Provide inputs to the BOPU Compliance Team (Legal, Medical, Operations, EHS)

- Act as member of the QCO network and interface to the Corporate/Global Quality organization; give feedback to Corporate/Global level quality initiatives and take actions on BOPU level

.9. The BOPU QCO is responsible for Deviation/CAPA Management, which includes:

- Ensuring effective Deviation and CAPA system is established and maintained

- Escalating quality issues (product, out contracted services, personnel)

- Act as/liaise with Local Pharmaceutical Complaint Officer (LPCO)

- Acting as main contact partner for quality aspects regarding follow-up activities of confirmed counterfeits.

2.10. The BOPU QCO is responsible for PQR, which includes:

- Performing and documenting PQR review by MAH (Marketing Authorization Holder) if required by local regulations (Note: PQR is generated by Manufacturer/ CMO/3PM).

2.11. The BOPU QCO is responsible for CSV & C, which includes:

- Establishes and maintains list of GxP relevant IT systems

- Represents local QA function in local/global IT project teams

- Reviews and approves validation documentation for local IT systems/client site systems in case of global systems

- Performs audits and self-inspections to ensure compliance with internal OCP/OCS requirements and external regulations.

- Acts as first contact during audits by authorities, in case of global IT systems present overall validation approach and liaise with validation function at Corporate.

Requirements:

Bachelor degree majoring in Pharmaceutics/Companyology/Chemistry
Significant experience (> 3 years) in a GxP regulated environment with extensive specialized QA knowledge.
Thorough knowledge of GxP\Quality and Compliance regulations with practical expertise in QC\QA\Manufacturing in pharmaceutical\vaccine industry.

Competencies critical for success of this job:

Defines issues clearly, prioritize activities and solves conflicts effectively with appropriate information sharing and proactive communication of critical issues
Builds bridges between the quality function and other functions
Promotes continuous improvement
Recruits, develops, coaches and executes performance management for assigned staff
Demonstrates a commitment to quality in all work. Sets high goals for standards, performance for oneself and others. Plans, does, checks, acts
Good negotiation and effective influencing skills. Develops and maintains constructive relationships internally and externally.
Must possess strong organizational, analytical and problem solving skills.
Willingness to travel
ACompanylity to appropriately balance compliance and business needs to ensure problems are identified, clearly articulated, escalated and resolved with the right sensitivity to timing, risk consideration and overall business impact.