Operational Quality Manager
Stiefel Laboratories, Inc
Western Cape, South Africa
9d ago

Your Responsibilities : Job Purpose :

Job Purpose :

Responsible for final release of products for sale to both local and export markets.

Responsible for operational quality support and oversight to site operations (including shift).

Accountable for effective and efficient delivery of site wide compliance training and adherence as required.

Assists with review of documentation for Periodic Product Reviews.

Assists with QMS & RMS updates required for Operational Quality.

Assists to facilitate GMP Compliance activities (Deviation Handling, CAPA management and Audits). Ownership of the deviation management system.

Scope : Final release of products for sale into the local and export market. Ensures that manufactured and imported products released for sale in Southern Africa comply with requisite quality and compliance standards.

Ownership of deviation system. Provide compliance support (assess Deviation and CAPAs, conduct and provide support on internal audits and monitors the BRFT KPI and document errors).

Essential Job Responsibilities :

1. MANAGEMENT

Manages the Operation Quality department in accordance with Site business strategy

1.1 Liaises with the QA Manager and the Laboratory Manager wrt matters related to product quality and compliance.

1.2 Monitors and measures performance wrt BRFT and acts on the data accordingly.

1.3 Inputs into Site goals and strategy wrt KPIs and continuous improvement.

1.4 Supports the implementation of new and existing policies / processes.

1.5 Liaises with SABS and Principals wrt tests and product quality where applicable.

1.6 Liaises with Contract Manufacturers wrt CofAs, test results and product compliance and release as applicable.

2. Production Release

Responsible for final release of products for sale into the local and export market (Includes all contributing processes and raw materials) according to local and international regulations (e.g. EU Annexure 16).

2.1 Ensures that products and materials are released / rejected as per documented requirements (e.g. TTS or quality agreements).

For EU release ensure Annexure 16 requirements are complied with.

2.2 Reviews product test data and IPC data to ensure that manufactured products comply with specifications.

2.3 Evaluates and approves QA IPC data and records.

2.4 Checks Manufacturing and Packing batch records including all supporting data, logs, charts, etc.

2.5 Releases (or rejects) manufactured product by signing CofAs and batch manufacturing and packing records accordingly.

2.6 Indicates disposition of rejected product on CofA and batch records.

2.7 Reviews product test data and supplier CofA for imported products against specification and TTS information and releases (or rejects) the product accordingly.

2.8 Effects release (or rejection) of products manufactured by Contractors by performing a documentation review of CofA and batch records and notifies Contractors by means of fax, letter or email accordingly.

2.9 Ensures that Vaccines released for sale comply with MCC requirements by : - - reviewing data from manufacturer and control laboratory.

  • ensuring sampling and submission of samples to control laboratory.
  • liaising with appropriate personnel / functions wrt cold chain maintenance.
  • 2.10Liaises with Commercial wrt testing, release and status of imported products as applicable.

    2.11Provides support to Commercial and Principals wrt provision of Cof As on GSK letterhead as applicable (for export purposes).

    2.12Ensures preparation of the appropriate CofAs as per TTS for exported product.

    2.13Ensuring systems in place that prevent the inadvertent release of product

    2.14Ensuring OQ and Production personnel are suitably trained on the product release process and their inputs to this process are clearly understood.

    2.15Ensures communication and liaison with 3rd party and export market QPs to ensure they are notified of any deviations / incidents and potential delays to supply.

    3. Deviation Management :

    Overall deviation system ownership :

    3.1 To assist relevant stakeholders to ensure that an adequate level of competence is developed across the site in terms of deviation management.

    3.2 To provide accurate metrics related to deviations (categorization, repeat deviations etc) as required

    3.3 To ensure OQ involvement in the deviation process as follows :

    3.3.1 OQ to provide guidance on the deviation classification and review remedial actions taken

    3.3.2 OQ to confirm the initial assessment of the deviation, including severity and any escalation requirements

    3.3.1 OQ to provide guidance on the scale of the RCAs required

    3.4 To review and approve the deviation records, an confirm the classification, once all the required information has been documented

    3.5 To monitor the OQ area periodic trend reviews of deviations, including assessment of effectiveness of actions taken.

    3.6 To ensure deviations with potential to impact marketed product are immediately escalated to the Quality Assurance manager

    4.Compliance / QMS

    Ensures compliance with GSK QMS, Pharmacopoeial and MCC and applicable regulatory requirements.

    4.1 Ensures efficient document and sample retention as per SOPs and QMS policy.

    4.2 Ensures correct control of product shelf-life (or extension thereof) as per SOPs and scheduling the retesting / replacement of stock as applicable.

    4.3 Ensures that scheduled (controlled) product and material are controlled as per MCC requirements wrt storage, permits and stock reconciliation.

    4.4 Ensures compliance with relevant quality, compliance legislation, SOP’s and GSK policy within Operational Quality, ensuring gap analysis conducted on time and adoption of CH SOPs as per specified timelines.

    4.5 Prepares and reviews SOP’s in accordance with requisite site and GSK procedures and standards.

    4.6 Provides the following compliance support

  • assessment of non-conformances / deviations / incidents
  • review of completed NCs and CAPAs.
  • GMP training.
  • 4.7 Initiates corrective and preventive action for problematic or rejected products.

    4.8 Conducts and provides support on internal audits

    4.9 Monitors the BRFT KPI and document errors.

    4.10Performs periodic product reviews as per SOP / QMS requirements.

    4.11Complies with change control requirements.

    4.12Actively participates in ZDP program to meet the standard of 10 per person per year.

    5. EHS

    Ensures compliance to applicable requisite GSK EHS Standards.

    5.1 Complies with EHS standards and guidelines and ensures preparation and review of applicable EHS SOPs as applicable.

    5.2 Supports implementation of new and existing EHS Policy.

    5.3 Actively participates in ZAP program to meet the standard of 10 per person per year.

    6. GSK Production System

    Ensures continuous improvement to reduce costs, increase productivity and improve quality.

    6.1 Ensures departmental processes are continually improved eg using GPS principles to drive performance.

    6.2 Initiates and participates in site improvement projects.

    Basic qualifications : Grade 12.

    Work Experience :

    Minimum of 4 years experience in a pharmaceutical environment. Knowledge of GxP, MCC & ISO 9000 requirements.

    3 - 5 years experience as an Quality / Compliance Auditor in a pharmaceutical or related industry

    Training : In-house induction.

    In-house induction.

    Relevant GSK policies procedures, processes and systems.

    GMP, QMS, EHS and GPS requirements

    Job specific curriculum (in-house) including

  • Core SOPs
  • On-The-Job training
  • Risk Assessment and Management

    Person Specification :

    Good organization and communication skills.

    Good knowledge and experience of QMS and Risk Management.

    Very good documentation skills.

    Assertive and results driven

    Excellent Leadership Skills.

    Excellent Interpersonal Skills.

    Excellent Organizational Skills

    Excellent Communication Skills

    Uses Initiative and is self motivated.

    Excellent Numeracy and Accuracy Skills

    Excellent attention to detail

    Ability to trouble shoot and solve problems

    Ability to work under pressure to deadline.

    Ability to work overtime and shift work if required

    Job Factors : Knowledge :

    Knowledge :

    The job holder must have :

  • Knowledge and understanding of GMP, QMS, and pharmaceutical manufacturing environment , and Regulatory requirements.
  • Good Documentation skills
  • A good understanding and knowledge of Good Manufacturing Principles with focus on OQ operations.
  • A good understanding, knowledge and applicability of the Regulatory (MCC) requirements within a manufacturing and testing environment.
  • A good understanding and knowledge of the EHS and QMS requirements relevant to the OQ function.
  • A detailed knowledge and understanding of Good Laboratory Practice, including OOS handling
  • A good understanding of business processes and controls within area of responsibility.
  • Sound management skills in order to effectively manage people, and interrelate within different levels in the organisation
  • A good understanding of the importance of and how to teach and coach personnel
  • Ability to write Technical Reports, etc
  • A good understanding of the GlaxoSmithKline Production System, the GPS standards and its integrated approach
  • Working knowledge of Microsoft packages EXCEL, POWERPOINT and WORD
  • Complexity : The job holder must :

    The job holder must :

  • Ensure alignment with increasing export market regulatory requirements
  • Balance the demands for OQ oversight and batch release with that of effective utilization of resources.
  • Strive for continuous improvement in operational efficiency, whilst maintaining compliance to EHS, GMP and general regulatory compliance
  • Be able to manage and guide complex RCA investigations.
  • Be able to communicate effectively with various market LOC and QPs
  • Have a very good understanding of the QMS requirements and remain up to date with changes
  • Independent Thinking :

    This position is highly governed by policy and procedures; however opportunity exists for independent thinking relating to improvement of processes and systems.

  • The job holder must be capable of using their own initiative, be progressive in approach and understand his / her limitations in terms of the Regulatory / QMS / EHS requirements applying the GSK judgment ladder in all decisions.
  • Responsibility :

  • Compliance with the Pharmacy Act 53 of 1974 and the Medicines % Related Substances Act 101 of 1965, requirements
  • Ensure OQ compliance to local SOPs and QMS
  • Ensure manufacturing compliance to GMP, safety (product and personal) and relevant regulatory authorities
  • Legally responsible for release of all products routed via the Cape Town factory. Ensuring products are not released before all compliance requirements are met.
  • Annual Strategic Planning : Ensures achievement of Site Objectives wrt Regulatory and QMS compliance

    Preferred qualifications :

    Why GSK? :

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