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

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

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:

Operational Quality Manager HTA Job in Karachi

Job Description