Major Accountabilities

Validation:

• Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.

• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, other specific validation and ongoing process verification (OPV), ongoing cleaning verification in alignment with the APQR. Author complex validation protocols regarding each validation activities.

• Ensure that all manufacturing and cleaning processes are validated, overview on state of validation at site is maintained.

• Ensure an appropriate process control strategy based on CQA and where necessary on CPP, CMA is in place, support improving the control strategy where applicable.

• Provide all necessary information to perform the validation documentation, align with stability experts and QC labs to organize the stability samples.

• Establish and monitor validation KPIs. Maintain all validation activities in an inspection ready status.

• Create and maintain a product specific Quality Risk Analysis (QRAs) and initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory (transfer of the product-specific QRA).

• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.

• Reviews risk assessments for validation and OPV, provide guidance to facility impact and component criticality assessments. Ensure data and trending are visible and communicated at shop floor level. Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.

• Author complex validation protocols. Establish local procedures & templates for respective validation documentation.

• Ensure that all Site validation activities are performed and are in line with cGMP requirements, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.

• Provide technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.

• Be a senior advisor in case of difficult validation challenges at Site.

• Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.

• Support Site TO Director in ensuring that responsible departments execute and maintain the VMP activities.

Partner with Engineering Production, IT, QC, etc to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation.Education (minimum/desirable):

• BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent.

Languages: Fluent in English and proficient in site local language.

Relevant Experiences:

• At least 3-5 year experience in executing process validation, having led and managed validation projects.

• Thorough understanding of manufacturing processes and related process equipment.

• Expert in reviewing and writing technical reports.

• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).

• Fundamental understanding of standard pharmaceutical analytical testing.

职位信息