Operational Quality Manager HTA Job in Karachi

Overview

Operational Quality Manager HTA Job in Karachi

Designation: Operational Quality Manager

Industry: Pharmaceutical

Qualification: Masters (chemistry/pharmacy/microbiology/Applied chemistry).

Experience: 6 years

Responsibilities & Authorities:

Planning & Coordination

• Support other functions by providing necessary help and good customer service to relevant departments.
• Maintain cordial relationship with all the stakeholders for the fulfillment of site goals.
• Set up KPI targets and achieve them in coordination with departmental manager.

Operational Activities

• Ensuring implementation of cGMP, SOPs and group policies.
• Ensuring and manage the activities/functions related to cGMP and In-process lab.

• Ensuring In-process checking during filling & packing operations according to SOPs and standard pack specification.

Batch Release

• Provide an effective product release service which ensures that all products released for processing & sale have a quality appropriate to their intended use i.e. comply with company GMP standards and product quality specification.
• Ensure proper compilation and review of batch dossiers.
• Ensure that batch dossier is retained as per local regulatory and record retention.

GMP Deviation Investigation

• Ensure that product quality issues are correctly investigated and that appropriate corrective measures are implemented.
• Ensure timely investigations & completion of actions.

Change Control

• Handling & coordination of change control with stakeholders and ensure timely closure.
• Develop the change control acceptance criteria with the consent of defined team.

Compliance And Procedural Implementation

• Participating in level II regulatory and corporate audits.
• Documents review before GQA audit.
• To ensure QMS compliance by interpreting and applying GQPs and GQMPs
• CEHS standard compliance
• Ensure the revision of SOPs, BMRs and SPS as and when required.
• Participate & give input in business continuity planning.
• Escalate quality issues related to materials/equipments in site quality meetings.
• Take actions against the observation of audits (L1 to L4) and carry out CAPAs.

Maintain Customer Complaints System

• Ensure the handling of complaints in timely manner.
• Ensure the handling of complaints as per SOPs and coordinate with group compliant coordinator.

Maintains Safe And Healthy Work Environment

• Implement EHS standards and guidelines.
• Identification, implementation and adaptation of good practices in OQ

People Management

• Compliance to corporate/HR policies.
• Maintain self and team PDPs, manpower plans and job rotations.
• Self evaluate, guide and coach on leadership framework.
• To implement training for OQ staff to ensure competence in performing the required function.

Site Quality Council

• Support the Head of Quality for SQC communication and minutes.
• Maintain the records of SQC data.

Maintains Process Standards

• Ensure that manufacturing, filling and packing activities are performed according to BMR, BPR and relevant SOPs.
• Approval of BPRs and SPS.
• Checking of BOM for packing operation.

Skills and Competencies:

• Knowledge of operations.
• Professional trainings
  • Leadership edge
  • Green belt certification/LMLS
  • Computers-XP
  • GQP/GQMP/EHS
  • OOS
  • MS office
  • Statistical software

Tagged as: HTA Jobs