Job Purpose and Key Responsibilities :
In conjunction with the Site Quality Director and Value Stream leader evaluate future business needs (e.g. Site Business Plan and Regulatory Intelligence) agree/design a strategy to ensure the Operational Quality Section meet these needs.
Drive change by delivering the strategy via means of culture change, modern technologies, organisation change and ways of working.
Ensure that products released for sale have been manufactured and packaged in accordance with the licensing requirements, Good Pharmaceutical Manufacturing Practice and business requirements, and to promote quality/compliance within the Product Streams. In addition, ensure that Products are available on time, complying with policies and standards, and exceed customer expectations
Key Accountabilities/Responsibilities
Release
Drive change by delivering the strategy via means of culture change, modern technologies, organisation change and ways of working.
Ensure that products released for sale have been manufactured and packaged in accordance with the licensing requirements, Good Pharmaceutical Manufacturing Practice and business requirements, and to promote quality/compliance within the Product Streams. In addition, ensure that Products are available on time, complying with policies and standards, and exceed customer expectations
Key Accountabilities/Responsibilities
Release
- In line with the requirements of the Value Stream Leader provide an effective product release service which ensures that all products released for sale or further processing have a quality appropriate to their intended use, i.e. comply with the export market, local Egyptian and Company GMP Standards and Product Quality Specifications.
- Ensure Quality Incidents and complaint management associated with products manufactured and packed within the Value Stream are managed in line with the QMS and local procedures.
- Ensure that there is effective management of investigations (including CAPA) and assessment of data from products failing to meet requisite standards and make decisions on rejection or rework in consultation with the Site Quality Director, Value Stream Manager and Site Director as appropriate.
- Influence Quality Improvement programmes and work with the appropriate Value Stream Manager and technical colleagues with the aim of reducing rejects and customer complaints and in so doing achieve a right first time/by first intent culture.
- Handle investigations of deviations, complaints and out of specification results, in coordination with production supervisors, Labs, Warehouse and ensures implementation of appropriate corrective and preventive actions and ensure investigation closure within specified time with intended Quality requirements
- Performs trend analysis on different quality systems and KPI's to support QA Operations to further improve the systems and results
- Contributes in site governance meetings to share and review trending results as to foster continuous improvement and manage risks
- Contributes to the quality strategy and the preparation of the Quality Plan for the site, prepares dashboards to communicate performance against objectives
- Sign-off the Stream Periodic Product Reviews.
- As appropriate manage the Quality sign off/approval of all quality related systems, procedures and documentation utilised within the Value Stream and ensures compliance with local Egyptian MOH and Company GMP Standards (i.e. QMS) and Product Quality Specifications.
- Manage the Quality and where appropriate the Technical interfaces between the Site and Auditors during Level 3 and 4 Audits.
- Implement an effective self inspection and independent business monitoring audit programme in Operational Quality with adequate follow-up actions.
- Ensure that any changes raised for Value Stream manufactured and or packed products have been appropriately validated and documented using the Site systems of approval. Manage the Quality Function sign off for Stream related Change Control Requests
- Ensures Documentation Management system e.g. SOPs, batch manufacturing and packaging records are applied to compliance check as well as alignment with method of production, process validation and regulatory files prior to
- procedure approval ; ensures all master production documentation is in line with validation and regulatory files prior to QA Operation approval
- Manage Documentation life cycle management and ensure that data integrity requirements are followed
- Organizes and takes the Quality Assurance responsibility for new projects (facilities –utilities – equipment – processes) in the site
- Drives a continuous Quality and Compliance mindset within the site to ensure compliance with cGMP’s and GSK Quality Management Systems as well as Regulatory Intelligence
- Maintains knowledge and experience up to date in the light of technical and scientific progress and changes in quality management
- Leads, selects, trains, evaluates, coaches and motivates team towards the pursuit of excellence and attainment of Good Manufacturing Practices
- Ensures optimal staffing levels and competencies are in place and ensures the retention, engagement and development of talent within the organization
- Manages people through effective performance management and labour relations excellence
- As a leader, personally role models and develops the team towards high performance behaviours
- Engages the team to deliver the GSK Vaccines, GIO and Quality strategy
- Is responsible for the compliance with all applicable standards and policies Change and continuous improvement
- Ensure that EHS policies and procedures are implemented during work and that all manufacturing and packaging processes are done per GSK requirements
- Represents quality during external regulatory audits in specific area of responsibility
- Deputise for the Cairo GMS Site Head of Quality as required and counterfeit incidents and ensure proper escalation in coordination with Site Quality Head
- Manage LIC, PIRC, Recall functions in coordination with Site Quality Head
Basic qualifications :
- University degree in Pharmaceutical science.
- 8-10 years of experience in a similar role or in QC function or production function within a pharmaceutical / biotech / medical device / food industry or equivalent environment
- Direct experience and knowledge of current GMP, MOH regulatory requirements and Quality management systems
- Proven experience in Quality Assurance within a quality department, and strong knowledge of cGMP and regulatory guidelines
- Experience in QA batch release
- Experienced in handling regulatory interfaces such as inspections
- Excellent documentation, report writing and communication skills.
- Familiar with IQ, OQ, PQ, facility, utilities, equipment and Strong experiences in product life management cycle
- Self-motivation, empowerment and adaptation to business changes.
- Strong prioritization and organization skills.
- Good command of English and computer skills.
- Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets.
- Internal candidates must have Exceeding performance for 3 Years
- 8-10 years of experience in a similar role or in QC function or production function within a pharmaceutical / biotech / medical device / food industry or equivalent environment
- Direct experience and knowledge of current GMP, MOH regulatory requirements and Quality management systems
- Proven experience in Quality Assurance within a quality department, and strong knowledge of cGMP and regulatory guidelines
- Experience in QA batch release
- Experienced in handling regulatory interfaces such as inspections
- Excellent documentation, report writing and communication skills.
- Familiar with IQ, OQ, PQ, facility, utilities, equipment and Strong experiences in product life management cycle
- Self-motivation, empowerment and adaptation to business changes.
- Strong prioritization and organization skills.
- Good command of English and computer skills.
- Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets.
- Internal candidates must have Exceeding performance for 3 Years
Job Details:
Job/career : Operational Quality Manager
Functional area: Quality
Location: Cairo, Egypt
Position: Full time
Open date: Aug 18, 2019
Required degrees: Bachelors
Learn More about GSK :
جلاكسو سميثكلاين( GlaxoSmithKline) واختصارها (GSK) هي شركة أدوية بريطانية عالمية , تقوم بالابحاث البيولوجية وإنتاج اللقاحات والأدوية الصحية الاستهلاكية.....( لمعرفة المزيد عن الشركة زورونا من خلال Meetup بالاسفل )
المقر الرئيسى : برينتفورد، المملكة المتحدة (انجلترا )
العنوان فى مصر: التجمع الخامس , القاهرة الجديدة
العنوان فى مصر: التجمع الخامس , القاهرة الجديدة
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