Overview
Quality Assurance Specialist (Maternity Cover) Jobs in Hoofddorp, North Holland, Netherlands at SUN PHARMA
Title: Quality Assurance Specialist (Maternity Cover)
Company: SUN PHARMA
Location: Hoofddorp, North Holland, Netherlands
Quality Assurance Specialist (Maternity Cover)
Who We Are
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$6 billion. Supported by more than 40 manufacturing facilities and more than 40.000 employees around the globe, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
Over the last two decades, Sun Pharma has established itself as a leading player in the generics market, and are rapidly ramping up their presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.
Values
At Sun Pharma our core values—Humility, Integrity, Passion, and Innovation—are part of our unique culture, known as Sunology.
We are empowering our employees to create their “Own Sunshine”. We believe in being Better Everyday by investing on lifelong learning, Taking Charge by owning our impact, and Thriving Together in a workplace where collaboration is encouraged. We are committed to being an inclusive and equitable employer, valuing diverse perspectives and creating an environment where all individuals feel respected, heard, and inspired to bring their best selves to work.
About the role
The QA Specialist is responsible for ensuring compliance in Sun Pharma’s products manufactured by SUN companies or third parties Non-Sun group (CMOs/CSPs). This includes supporting other roles like Qualified Persons and/or Quality Assurance Manager on product development and commercial operations, in addition to ensuring on-time release of product under release responsibility assumed by SUN Europe, The Netherlands plus appropriate maintenance of local quality systems. She/he ensures that activities at Contract Manufacturing Organizations (CMOs) and or Contract Services Providers (CSPs) are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement and Regulatory expectations. Supports the QMS that consolidates Health Authority Regulations into Sun Quality requirements for products under scope.
Major tasks & responsibilities:
- Management of weekly QA batch release planning of Biologic products and/or Branded products.
- Review documentation supporting batch/es certification to be done by QP to ensure compliance with GMP and with Marketing Authorizations (MAs) as well applicable and correct documentation for release (CoA, CoC, etc.)
- Management (initiates, investigates and ensures timely closures) of key quality systems including deviations, temporary change controls, change controls, CAPAs, complaints associated with the products, by liaising with CMOs, other QA members or QPs, operations, QC staff and other Sun stakeholders associated with Drug Substance/API, Drug Products or Medical Devices appropriately and in a timely fashion.
- Lead and organize periodic quality meetings to evaluate the status and timely closing of Change Controls, Deviations, and CAPAS with CMOs/CSPs, internal departments (Supply Chain and RA), process and product-related.
- Supports technology transfers and process/ analytical method validation activities from quality operations perspective when required.
- Preparation and compiling information for annual product reviews (APR/PQR) of Sun products.
- Manages and maintains product specification in accordance with current marketing authorizations and ensure timely updated of applicable associated documentation in support for batch release.
- Review, prepare batch document for QP assessment for Batch/es release for markets where commercial batches must be supplied.
- Responsible for receiving, managing, and tracking CMO change notification; performing timely communication with both internal and external internal stakeholders according to the requirements of Quality Agreements.
- Ensures the comprehensive use of risk management tools in aspects across the quality management system, and product related elements to assess impact on product quality, and overall compliance with regulatory expectations and with the marketing authorizations.
- Works closely together with the Quality System Managers to support the QA IT systems (eDMS, TW, eLMS, etc) and acts as a back-up for QA IT systems activities if required.
- Support the timely implementation of global standards and procedures by execution of associated GAP assessments against local procedures.
- Support the maintenance and update of Quality Management System.
- Support planning and inspection readiness for external audits (from partners, Corporate Quality Systems and regulatory authorities
- Keeping compliance to SUN Global Quality Standards and SOPs by drafting SOPs from the local level, if needed.
- Play a key role in providing continuous improvement and global standards alignment.
- Business and Operations support as required, including but not limited to:
- Involvement in new projects under GxP context.
- Communication with manufacturing plants for optimization and process Improvements
- Support the maintenance and update of local Quality Management System.
- Offering support to ensure that all outsourced manufacturing and analytical activities are clearly defined, agreed, and effectively controlled to maintain product quality and compliance with EU GMP Chapter 7.
- To collaborate to ensure a continuous validated state for all manufacturing and testing process as per EU GMP Annex 15
- To collaborate in compiling data to ensure appropriate legal status of Customers are supplied with Medicines and that supply chain is monitored to ensure GDP compliance in collaboration with Logistics areas.
- Drafting and reviewing Quality Agreements with third parties SUN Group or Non-SUN group when needed.
- Ensure trainings are managed timely to ensure GMP/GDP compliance and aligned to Authorities expectations.
Additional Responsibilities per Quality Team:
Branded:
- Responsibility for reviewing, approving, and tracking Sun Pharma QMS and CMO change notifications with direct impact to the product quality or patient safety and the related unplanned deviations while also performing the tasks as outlined in the Quality Technical Agreements.
- Aware of content of Mutual Recognition Agreements (MRAs) are effective among Europe (EMA) and Authorities in third countries, to ensure that certification by EU QP within EU legal context is applicable and recognized by the third party.
- Responsible for the preparation and archiving of monthly and quarterly CMO’s risk assessment reports.
- Ensures that the QP register is prepared, approved and archived on a monthly or regular basis.
- Support the planning, execution, and tracking of new CMO projects or launching of new products.
- Responsible and/or support the planning of batch releases
Qualifications, Knowledge, Experience & Skills
Education Qualifications (Graduate- Post Graduate)
Mandatory
- HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
- Minimum of 3 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
- Well versed in Microsoft Excel.
- Fluent in English
Preferred
- Industry: (Bio) pharmaceutical, sterile manufacturing
- Content areas: Manufacturing, QA /QC. QA manufacturing operation.
Note: Additional experience managing Biologics products as Drug Substance and/or Drug Product could be required for role or for IMP’s management could be required, too.
Strong knowledge of EU GMP and other legislations effective worldwide if product is supplied to third countries could be appreciated and required, too.
Work experience
Mandatory
- Tenure: minimum 3 years
- Industry: Pharmaceutical, sterile manufacturing
- Content areas: Manufacturing, Regulatory, QA/QC. QA operation.
- Strong knowledge of EU GMP, US CFRs.
Preferred
- Content areas: Manufacturing, Regulatory, QA/QC. QA operation.
Technical skills/job specific competencies
- Experience on preparation of batch release, including batch documentation review and preparation for batch certification.
- Strong cGMP experience and knowledge, QA/QC and regulatory compliance (US, EU and other international agencies)
- Advanced knowledge and experience in API/DP biopharmaceutical operations, QA/QC processes and contract manufacturing.
- Good understanding of complex change control processes and interaction with regulatory affair processes.
- Good understanding of regulatory submission processes.
- Capable of reviewing and assessing manufacturing and analytical technical documents and provide sound quality assessments on change controls, deviations and complaints.
- Experience working with electronic Document Management, electronic Training systems and e.g. Trackwise
- Understanding of risk assessment and risk management fundamentals/tools
- Experience interacting with external parties.
- Good knowledge of MS office and Windows based computer applications.
Behavioral Skills/Competencies (e.g. excellent communication skills, strong collaborator, Problem solving etc.)
- Strong interpersonal skills, excellent communication skills, good presentation, negotiations and influencing skills
- Ability to effectively manage multiple, complex priorities and quick shifting of those.
- Team player, task oriented and keen on working in a cross-cultural working environment.
- People oriented with tendency to help others and go beyond her/his area of responsibility.
