Quality In charge

We are seeking for Quality Assurance Manager for our Faisalabad Plant at FIEDMC.

To monitor and manage the activities of Quality Assurance department and to assess the compliance of facility, equipment, processes and procedures with cGMP, ICH, Quality management System ISO 9001:2015, 13485:2016, DRAP guidelines, Pharmacopeia Requirements and all other applicable regulations.

Responsibility:

Operational:

• Provide high level of technical & professional expertise for the implementation of defined Quality systems (QMS), standards and procedures in whole Plant.
• Review and approve all Standard Operating Procedures (SOPs), protocols, technical reports, and validation documents.
• cGMP compliance in the Production, Quality control, Supply chain, R&D and E&M Departments as per regulatory guideline.
• Responsible for all validation related activities and provides a technical support for concerned departments.
• Identify cGMP gaps in whole plant and plan to mitigate these gaps by continuous improvement.
• Oversee batch record review (BPR) to ensure compliance before product release.
• Train & develop Technical Staff in technical & professional knowledge & skills.
• Lead deviation investigation and root cause analysis (RCA) and ensure timely implementation of effective Corrective and Preventive Actions (CAPA).
• Manage the Change Control system, assessing potential risks and coordinating cross-functional evaluations.
• Conduct internal audits as per schedule to evaluate compliance with GMP and company policies.
• Prepare and coordinate for regulatory inspections and customer audits, including documentation review and site readiness.
• Maintain up-to-date knowledge of current regulations and industry best practices, ensuring alignment of internal policies.
• Conduct GMP training programs for production, QC, warehouse, Engineering and other relevant departments.
• To assure Validation master plan for the facility, utility and equipment to ensure that they are all adequately validated for the cGMP projects undertaken within the facility.
• Establishing, developing, communicating and sustaining validation strategy, master plan and requalification schedules.
• Ensure calibration and qualification of instruments and equipment are performed as per schedule
• Implementation of new guidelines as following:
• Process Validation.
• Cleaning Validation.
• Storage areas Qualification (including conducting thermal mapping studies)
• Heating, Ventilation and Air-Conditioning (HVAC) Qualification.
• Clean room Qualification.
• Computerized Systems Validation (CSV)
• Pharmaceutical Water Treatment Qualification.
• Process Air Qualification.
• Production Equipment Qualification.
• Laboratory Instruments Qualification.
• Balances and IPC Instruments Calibration and Qualification.
• PQR Preparation
• Monitor and trend quality KPIs (e.g., deviations, CAPAs, complaints, OOS/OOT, etc.) to drive continuous improvement.
• Work with Operations and other QA members to perform risk assessment plans for all products processing and cleaning activities.
• Ensure good documentation practices (GDP) are followed across all departments.
• Ensure timely investigation and closure of market complaints and product recalls, if required.
• Participate in cross-functional teams for quality improvement initiatives, tech transfers, or process changes.
• Control issuance, revision, and archival of GMP documents, including master records and forms.
• Establish and maintain risk management practices (e.g., FMEA) for proactive identification of quality risks.
• Provide leadership, coaching, and performance management for the QA team members.
• Control Quality Agreements with third-party manufacturers and service providers.
• Ensure timely reporting and escalation of critical quality issues to senior management.
• Implementation and following up the applying of cGMP guidelines in all quality related departments in the factory.

Strategic:

• Collaborate cross-functionally to drive continuous improvement and support production goals.

Developmental:

• Contribute to team building, training, and problem-solving initiatives
• Professionally develop analysts to improve on individual and overall performance.

Performance Results

• Compliance of cGMP and ISO Standards requirements
• Effective communication with QC, Production and other departments for overall improvements
• Contributes to completing project milestones, organizing work to meet project deadlines
• Quality Standards Knowledge
• Pharma & Medical Devices rules & regulations.
• Leadership and Team Management
• Strong Analytical Skills
• Problem Solving Abilities
• Process Improvement Mindset
• Reporting Documentation
• Technical and Communication skills

Education & Experience Requirement:

• Master in Chemistry from recognized Institute with min. 10 years experience in a reputable pharmaceutical company.