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Senior QA Manager (Manufacturing)

Pfizer


Location:
Tuas South Ave 6
Date:
01/26/2018
2018-01-262018-02-26
Pfizer
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Job Details

You will be required to achieve the site Quality Assurance operational objectives by contributing information and analysis to the manufacturing Value Stream Teams (VST) functions. In this Senior QA role you will support the Senior Quality Assurance Manager (QSRCV) (who oversees the Quality Systems, Regulatory, Compliance and Validation team) by ensuring that your team of Quality Assurance Specialists are adequately mentored and coached to provide the necessary Quality oversight to the manufacturing Value Stream Teams by;



Quality Assurance in Manufacturing , Cleaning and Solvent Recovery plans and reviews,



preparing and completing strategic and ongoing action plans across all these areas,



implement manufacturing, productivity, quality, and customer-service standards,



identifying and resolving deviations in relation to API manufacturing, equipment cleaning and solvent recovery operations,



QA oversight to non-process related activities (engineering, automation, warehouse)



determining quality system improvements and implementing continuous improvements,







You will be required to develop strategic and system action plans by conducting hazard analyses, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures. You will ensure that the quality systems, the products manufactured and Good Manufacturing Practice (GMP) related operations observe consistent compliance with cGMP, Pfizer Quality Standards (PQS) policies, site Standard Operating Procedures (SOPs) and regulatory guidance.



Quality Control activities on site are managed independently from the Senior QA Manager roles.







Working across all site functions to accomplish site-wide QA manufacturing, cleaning and solvent recovery objectives the incumbent will have an excellent knowledge of cGMP, cGLP, cGAMP and knowledge of active pharmaceutical ingredient (API) manufacturing and the associated validation principles and extensive regulatory audit experience. The incumbent will interact with all departments on site and will need to be a self-starter with good interpersonal skills and excellent written and oral communication skills the incumbent will lead a team of QA professionals and will need to be action-orientated and a strong leader for the quality culture of the site.







As the Senior Quality Assurance Manager (Manufacturing) you will:



Develop and communicate appropriate objectives, priorities and metrics for the team.



Instigate a culture of lean operations by reviewing existing work practices and reducing non-value added activities in a systematic manner.



Ensure all manufacturing, cleaning and solvent recovery process and operations remain in full compliance with Regulatory filings and submissions.



Ensure the appropriate systems are in place such that the site operations meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site: responsible for batch disposition.



Manage the timely release of equipment following cleaning processes ensuring that equipment cleaning is reviewed and meets limits prior to release for use.



Review and approve manufacturing, cleaning and solvent recovery operational instructions, change controls, recipe changes/revisions in catalyst and DeltaV, and all non-process related (engineering, automation, warehouse) change controls.



Review and approve quality operations and production quality assurance reports and investigations for deviations from approved manufacturing, cleaning and solvent recovery processes or specifications when and where required.



Enhance site technical staff's knowledge of current Good Manufacturing Practice (cGMP); current regulatory requirements; Good Automated Manufacturing Practice (cGAMP) and general validation principles.



Coordinate Annual Product Reviews Reports (APRRs) when and where required.



Coordinate, develop and track Quality Operations metrics linked to MQA, QSRCV and QC teams.



Support, promote and demonstrate corporate and Pfizer Global Supply (PGS) vision, values, and leader behaviors.



Allocate department staffing and manage the utilization of facilities and equipment to ensure that departmental objectives are met.



Conduct performance assessment and development reviews of staff as part of the department development efforts.



In times of absence of the Senior Quality Assurance Manager (QSRCV) and, as directed by the Quality Operations Director from time to time, take up the responsibilities of the Senior Quality Assurance Manager (QSRCV).







You need to possess a Degree in Chemistry, Engineering, Pharmacy or a relevant Science discipline.







You should have a minimum 8 years of directly related experience in pharmaceutical manufacturing, or highly regulated industry and have a sound knowledge of QA/QC/Regulatory/Validation/Quality Systems and audit and supplier management experience, or equivalent combination of work experience and education. You need to have experience in hosting regulatory inspection such as FDA and are competent as a Level II Auditor.



You should have a minimum 5 years in a supervisory capacity. Experience in an API manufacturing plant is preferred. Related experience in at least two different pharmaceutical manufacturing facilities is preferred.







You should display having good knowledge of cross functional business processes, project management and risk management skills. Good people management and leadership skills are expected. You should have sound knowledge of Lean Sigma tools.







\#LI-CB1



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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