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Audit Manager, MSQA

Pfizer


Location:
Remote, OR 97458
Date:
02/01/2018
2018-02-012018-03-04
Pfizer
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Job Details

Audit Manager, MSQA



**Role Summary**



Pfizer is committed to the delivery of safe and effective products to patients and consumers, a



Fundamental element of our Company's Purpose and Mission. To meet this commitment, Pfizer



maintains a quality-focused culture to ensure the highest priority is placed on the safety, efficacy



and reliability of our products, the safety of our patients and consumers, the quality of data supporting regulatory submissions, and interactions with our stakeholders.







The Audit Manager MSQA position is responsible for performing cGMP audits and assessments of Pfizer sites, contract vendors and select suppliers. The Audit Manager MSQA will assess programs, processes and procedures to assure compliance with policies and that the performance and quality of services conform to established standards and regulatory agency guidelines. This position leads audit and inspection preparation, resolution of audit and inspection findings and liaises with appropriate site and quality oversight teams through all stages of the audit. The Audit Manager MSQA also contributes to enabling a culture of excellence and to the continuous improvement of the company's quality management system through engagement with Pfizer site audit teams to incorporate audit lessons learned across the Network. Quality: http://www.pfizer.com/about/quality







**Role Responsibilities**



As assigned, independently conduct, participate and lead audits and assessments of contract manufacturers, select raw material suppliers and service providers, PGS sites that manufacture and distribute finished product and API, as well as Pfizer Country Office locations that have affiliate quality operations responsibility.







Assess adherence to relevant regulatory GMP guidance documents, Pfizer Quality Standards, Functional and local SOPs and Pfizer expectations.







+ Assess whether employees are being properly trained for their responsibilities



+ Assess continued adequacy of the facilities and equipment being used for manufacturing and testing of finished product and APIs



+ Assess the concepts of cGMPs and compliance with requirements in the quality agreement and/or with Pfizer expectations / standards.



+ Assess and report weaknesses that could lead to non-compliant manufacturing and/or distribution of products.



+ Assure that the facility / supplier / contract manufacturer is executing activities (manufacturing, testing, regulatory compliance) per Pfizer Quality agreements / expectations.



+ Communicate relevant quality, EHS and business information to the facility / supplier / contract manufacturer in an effort to maintain and enhance the relationship between the audited entity and Pfizer.



+ As assigned, aid the PGS site or applicable contract manufacturer in preparing for upcoming regulatory inspections







Participate in Pfizer audits at the facility / supplier / contract manufacturer. Responsibilities for this activity include:







+ Assisting in scheduling the audit or schedule the audit.







+ Actively participating in the audit as directed by the lead auditor or lead the audit.



+ Reviewing the audit report and assist in developing acceptable remediation plans.



+ Performing a follow-up as needed or as directed by PGS leadership







Maintain the appropriate database with any relevant information pertaining to the facility / supplier / contract manufacturer audit.







Maintain and expand current knowledge of applicable laws, regulations, guidelines, and other pertinent policies, procedures, and standards that could impact the facility / supplier / contract manufacturer.







Liaise between the facility / supplier and the appropriate Pfizer group to ensure that any and all pertinent information is communicated such as any regulatory activity, any changes that are requested by Pfizer or the supplier or any pending or active regulation that may have an impact on the supplier's or Pfizer's business.







Conduct and participate in due diligence site assessments as required to determine compliance levels.



Able to engage with peers, sites and subject matter experts to embrace a culture of excellence that is independent, fair audits as well as effective CAPAs. Additionally;



Able to be part of a diverse audit team



Able to communicate and interact with peers and colleagues.



Able to apply regulatory audit trends to audit plans.







**Qualifications, Experience and Skills:**



Bachelor's Degree, preferably in the natural sciences, or equivalent required.







Progressive, challenging experience in pharmaceutical, biotech industry required (experience to include quality control / assurance, manufacturing, GMP auditing and may include product development) including:







+ Experienced in operational risk and compliance management, including experience in Quality auditing across a variety of dosage forms (e.g. analytical, API, biologics, aseptic, drug product, medical device) and "audit targets"



+ Must understand a variety of quality/operational systems that support contractor and supplier audits and quality supply chain management.



+ Has a good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations and In-depth knowledge of cGMP regulations trends and expectations and familiar with other GXP concepts and global regulations (FDA, EU, TGA, PIC/S, etc.).



+ Understands GMP requirements (PQSs, local regulations, and regulations where the material / product is marketed), practical understanding of the facility operations.



+ Is qualified in at least three of the technical skill sets (analytical, API, biologics, aseptic, drug product, medical device) applicable to the facility audit. (Recognised Auditor certification preferred).



+ Critically evaluates information from the facility and the team and makes clear recommendations, and is able to propose potential solutions.



+ Must be adept at managing multiple tasks and changing assignment based on changing priorities.



+ Good organisational skills (audit preparation, audit conduct, audit tracking) and issuance of audit reports aligned with MSQA audit metric targets.



+ Has the ability to recognise symptoms of problems or situations that require further evaluation, analyse symptoms to determine potential causes, suggest possible corrective actions.



+ Ability to work independently and work well in a team as a lead auditor or participant, and an effective communicator to peers, Quality leaders and managers



+ Actively works to achieve a balanced audit plan, supportive of urgent audit requests and flexible to changes.



+ Audit reports are written to reflect the required style and content, with findings levelled appropriately, and applying 'write right' and 'right first time' principals.



+ Ability to conduct ad hoc Quality assessments (e.g. Data Integrity, due diligence) as required to support business needs.



+ Ability to travel globally between 40% (minimum) to 60% of time.







**Closing Statement**







This position holds a UK Salary Grade 10.







The closing deadline for applications is Thursday 15th February 2018







We will only accept applications from colleagues via the formal route within Workday. Please do not submit paper or e-mail applications.







In line with good development planning, colleagues should discuss their suitability and/or readiness for a vacancy with their line manager prior to application. Colleagues are required to inform their manager if they are invited to attend interview. Where a line manager is not able to support an application either for suitability, readiness or business reasons, and a colleague continues to make an application, it is possible that an offer may not be made or may be withdrawn.







Applications not received by the closing date will only be accepted in exceptional circumstances and will require the support of your senior management team.







All applicants must have the relevant authorisation to live and work in the UK.







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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