- BSc. in Pharmacy / Pharm D, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
- Minimum 3 years of operational and/or managerial experience in case of MSc or Pharm-D.
- Minimum 5 years of operational and/or managerial experience in case of BSc. in Pharmacy, Pharmaceutical Technology, Chemistry.
- Good communication skills and interpersonal skills
- Good working of Microsoft Office (Powerpoint, Excel, Word, etc.)
- Desirable MSc. post above mentioned qualifications
- Experience in Pharmaceutical manufacturing, Data handling and Descriptive statistics
This vacancy would be based in our Jamshoro Office.
The incumbent would own the process knowledge of the products) assigned throughout the commercial life cycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring processes) are robust, in continued state of validation and continuously improving. The incumbent would also ensure seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the products). Provides second line technical/scientific process support.
- Maintain the oversight of the process of the products) assigned 'door to door' at the Site (e.g. from raw materials to primary packaging).
- Maintain the knowledge and the history of the products) process throughout the entire commercial life cycle, since transfer from development to date.
- Create and maintain a product specific Technical Risk Analysis (TRAs).
- Track CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned products) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc) using statistical analysis and conducting regular product specific data trending. Utilize data trending and statistical analysis to:
Deepen and broaden process understanding and knowledge.
Detect issues in process capability, such as systematic quality defects.
- Issue quarterly/annual data trending report.
- Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory (transfer of the product-specific Quality Risk Analysis).
- Ensure data and trending is visible and communicated at shop floor level.
- Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
- Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.
- Actively participate and represent their products) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, prioritized and monitored.
- Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.
- Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples.
- Plan re-validations / verifications /AMB together with the validation lead, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts.
- Participate and/or lead (case by case) the change controls to its products and related processes.
- Ensure alignment of (regulatory) time lines for technical changes (e.g. DS), transfers or launch, major deviations.
- Review the PQR data and provide the correct level of discussion on it.
- Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.
- Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit.
- Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
- Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
- Any other responsibility assigned from time to time as per business requirements.
You may apply for this position online by selecting the Apply now button.
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