北京招聘

Job Title JOB TITLE: Validation Champion
Department: MS&T (Manufacturing , Science and Technology)
Reports to (Job Title) REPORTS TO: MS&T Head


Job Purpose (State in one sentence the overall objective of the role)

To implement and manage site process validation, packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements and related SOPs; To benchmark against internal Novartis and external industry standards with the aim of achieving best-in-class standards and practices, expanding and sharing knowledge throughout the rest of the site and network; To liaise effectively within internal and external functions and provides expert training on validation topics.



Major Accountabilities (Describe the 5-7 main results of the role to be achieved )
(Describe a maximum of 8 main results of the role to be achieved) (here there are 12 results!)
1. Develops the strategy for continued process verification (CPV) strategy that ensures all critical process parameters and quality attributes are monitored or analyzed and actions taken in case of trends or deviations. Reviews risk assessments for CPV.
2. Ensures "continued process verification' plans are in place to monitor and trend critical process parameters and quality attributes
3. Establishes and manages the respective validation plans by aligning, coordinating and supervising the prioritisation of activities against the business needs. Reviews risk assessments for validation.
4. Ensures that all respective validation activities are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from major or complex changes.
5. Sets local/global procedures & templates for respective validation documentation and validation master plan
6. Authors complex validation protocols (e.g. launches, transfers, weak point remediation). Reviews or authors routine re-validation protocols and reports, approves MBRs and associated change controls and supports the execution at the shop floor.
7. Participates in transfers and launches, contributes to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation (e.g. P35 module).
8. Supports equipment process qualification for new technology. Ensures consistency with process needs defined by PU and/or Engineering. Writes, reviews and revises any SOPs related to validation activities, provide guidance to facility impact and component criticality assessments
9. Provides input to QM/QD/global SOP and technical guidance documents to ensure that the document is in line with global/local requirements and industry standards
10. Provides technical expertise and participates in the improvement and remediation of products in the product improvement portfolio.
11. Maintains all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities
12. Owns the Training Curriculum for its Job Description and provides the necessary training and support to new associates joining this position



Key Performance Indicators (Indicate how performance for this role will be measured)

1. Meet established validation and revalidation milestones according to approved validation plans
2. No critical/major observations during audits/inspections
3. Transfers/launches implemented on schedule and on target without validation related issues. Deliver validation data that meet the target schedule and quality to support the required registration documentation.
4. All related SOPs are updated on time.
5. Weak products remediated according to PIP timelines.
6. Validation/revalidation activities scheduled in a timely manner that do not adversely impact production schedule nor audit readiness
7. Training curriculum up-to-date. New associates trained according to the training curriculum.

Dimensions of the JobJob Dimensions (Indicate key facts and figures)


Direct reports: none
Number of associates:
Financial responsibility:
(Budget, Cost, Sales, etc.)
Impact on the organisation:





Ideal Background (State the preferred education and experience level)

Education ( minimum/desirable):
B.S, M.Sc in Pharmacy, Chemistry, Chemical/Pharmaceutical Engineering; Ph.D preferred

Languages:
Fluent in English
Experience: Minimum of 8+ years of experience of validation or process engineering in the pharmaceutical or bio-pharmaceutical industry.
Minimum of 8+ years of hand-on validation or pharmaceutical process engineering experience preferred.
Knowledge of statistical process control and manufacturing processes and related process equipment.
Must have working and in-depth knowledge of FDA / ICH guidelines, EU, and ASTM applicable regulations and standards routinely used in the industry, validation principles.
Experience in executing process validation.
Excellent interpersonal, written and communication skills.
Led and managed validation projects.

Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘