Job ResponsibilityQuality Officer
Pharmaceutical Industry
Supply Chain & External Supply Quality (SC&ESQ)
1 Year Contract
Bangsar, Kuala Lumpur
Monday - Friday
8.30am-5.30pm or 9am to 6pm; (occasional meetings outside standard working hours are expected for this role)
Position Purpose
The main responsibility of the Quality Officer is accountable to support the maintenance of an appropriate and sustainable Product Quality System and Quality Culture at the Client's Country Office (PCO) in order to ensure compliance with Client and Regulatory Authority expectations. The Quality Officer will also be responsible for the investigation and resolution of all product quality issues discovered or originating in the PCO and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Global Supply Chain (GSC), Medical, Commercial BU) and PGS on such issues. The Quality Officer will also monitor the product quality and compliance activities at the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GDP inspections.
The Quality Officer will be accountable for the support of implementation and compliance to SCQ (Supply Chain Quality) Functional and Global SOPs and any other Client's Quality Standard requirements as the primary contact point for business partners both internal and external. The Quality Officer will also be accountable for the supply of compliant products into the Malaysia and Brunei markets, ensuring adherence to Good Manufacturing Practices/ Good Distribution Practices for Medicinal Products.
Duties
Deviation Management
Support cross-functional investigation team for deviations that occur within the responsibility of SCQ organization, agrees and tracks corrective/preventive actions.
Product Complaint management
Manages the intake and triage of complaints from the PCO in a timely manner, tracks complaint responses.
Develops and submit final responses (if required) related to investigation (to be provided to the complainant) for approval; respond to complainant in a timely manner.
Notification to Management
Informs SCQ Cluster Lead of significant deviations and complaints as well as any issues impacting marketed product within the required timeframes.
Support Quality Review teams to ensure cross-functional input into issues
If required, attends Area Quality Review Teams (AQRT) meetings, as Market PCO representative, to provide the local perspective on the issue at hand.
Support implementation the actions identified from Area Quality Review Team (AQRT) or Enhanced Quality Review Team (eSQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions
Support local market action team and ensure effective completion of all required actions i.e. recall.
Product Quality System
Support implementation of SCQ Functional and Global SOPs and any other Pfizer Quality Standard requirements. This includes but is not limited to ensuring all relevant PCO colleagues are appropriately trained.
Report and review data and metrics on PCO quality performance and present in Management Quality Review.
Support assessment of compliance of product quality systems & processes to identify improvement opportunities.
Support the assessment of new quality system/local regulatory requirements and adjusts/enhances local quality systems and processes, when required.
Manage Quality Systems such as Commitment Tracking and Change Control. Ensure timely completion of actions.
Participate in risk assessment and apply Quality Risk Assessment tools as necessary.
Inspections and Internal Audit
Participate in Self Inspection for SCQ scope of activities
Support the preparation and facilitation of GMP/GDP related inspections of PCO by Regulatory Authorities or internal auditors.
Prepare and agree with SCQ Cluster Lead and the applicable PCO colleagues on responses and action plans to address issues identified during GMP/GDP related regulatory inspections or internal audits.
Communicate regulatory inspection observations and RQA audit findings to SCQ Cluster Lead and provide input into CAPA plans
Facilitates Pfizer Regulatory Quality Assurance (RQA) audit process at the contractors, which includes improvement, follow-up and communicate action closures.
Local Product Disposition
Performs local release of imported products, in compliance with the applicable local regulations and local procedures, prior to sale within country. This includes temperature excursions resolution and compliance with registered details.
Performs evaluation and disposition of returned stocks according to Pfizer Quality Standard requirements
Ensure that Quarantine Alert Notices received are processed in a timely manner
Perform risk assessment if required.
Repackaging and Relabeling
Ensures all operations are performed in compliance with Pfizer Quality Standard requirements.
Ensures Repackaging and Relabeling facility has been assessed and approved.
Ensure the approval of the relevant repacking/ relabelling request forms are obtained
Ensure regulatory approval of the Repackaging and Relabeling activity is obtained, if required under the local regulations.
Ensure products are repacked/relabelled according to the repackaging/relabelling instruction with accurate documentation related to repackaging/relabeling operation and releases for distribution.
Development and Maintenance of Consistent Quality Culture
Supports SCQ Cluster Lead in providing ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.
Drive Stakeholder Value
Quality contact point for internal and external business partners.
Qualification
Bachelor's Degree in Science, Engineering or a related discipline
Preferred candidate from Quality background (prior experience in Quality). The pharmaceutical industry is the preferred option.
Candidates with Quality background from non-pharmaceuticals will be considered (FMCG).
A minimum of 3-5 years in the pharmaceutical industry, preferably in a quality role.
Knowledge, experience, and application in Quality Management systems.
Knowledge of current Good Manufacturing Practices/ Good Distribution Practices
Knowledge and experience and application of local regulations.
Strong interpersonal skills; ability to communicate across all levels of the organization and also use communication to demonstrate the value of the quality organization
Ability to interpret and analyze data with problem-solving skills
Professional written and oral communication skills in English is a must
Job RequirementsJob Benifits
