Chemical Manager

Thornton Tomasetti; Landhi Town; On-site; PKR 1,800,000 - 3,000,000; Full time

Job summary

Abbott in Karachi, Landhi, Pakistan is seeking a QC/QA specialist to support the Quality Control Manager in Cleaning Validation, CSV, and PQR processes. You will assist in planning, data collection, and reporting to enable timely CAPA recommendations.

The role requires MSc Chemistry or Pharm-D with 8–10 years in QC/QA, strong method knowledge, and experience with validation protocols. This position offers exposure to global standards in a manufacturing environment and opportunities to contribute

Qualifications

• M.Sc. Chemistry or Pharm-D with 8-10 years of QC/QA experience.
• Knowledge of Cleaning Validation, CSV, and annual product quality review.
• Familiarity with SOPs and validation activities across QC/QA.

Responsibilities

• Support QC activities related to Cleaning Validation, CSV and PQR.
• Assist in planning the PQR Annual plan and data collection for reporting.
• Prepare and review validation protocols, reports and CAPA recommendations.
• Review policies, SOPs and change controls for validation activities.
• Collaborate with QA and other sections during self-inspections and audits.

Skills

Quality Control

Quality Assurance

Cleaning Validation

Computer System Validation

PQR process

Data analysis

Documentation

Education

M.S. Chemistry

Pharm-D

Tools

SOPs

CVMP protocols

Job description

JOB DESCRIPTION: Provide support to Quality Control Manager in managing QC activities related to Cleaning Validation, Computer System Validation and Annual PQR process.

Major Responsibilities

• Prepare PQR (product Quality Review) Annual plan and implement it in timely manner.
• Collect PQR related data from all stakeholders, review and analyse data and prepare PQR report.
• Share PQR findings / observations / trends with respective sections and Senior Management for appropriate CAPA/recommendation.
• Cleaning Validation Preparation of Cleaning Validation Master Plan (CVMP), protocols and reports with worst case selection as per recent guidelines and products at site.
• To ensure Cleaning Validation activities related with Products, Processes, and Equipment.
• To provide support to QC in conducting glassware cleaning validation.
• Conduct Cleaning validation and revalidation via preparing cleaning validation protocols, relevant documentation as per Master plan.
• Perform and manage cleaning validation sampling activities along with QA support.
• Revision of cleaning validation schedule as per production and supply priority as per their request and consensus.

Computer System Validation

• Prepare annual Computer System Validation Master Plan (CSVMP) of QC equipment and ensure adherence, prepare, and communicate monthly computer system validation plan to all stake holders.
• Prepare protocols and reports of computer system validation and to perform computer system validation activity accordingly.

General Responsibility

• Review of applicable policies and align SOPs (related to PQR, cleaning validation, and computer system validation).
• Implementation and compliance of all the SOPs and applicable policies and procedures.
• To review and complete change control tasks with respect to Cleaning Validation, Computer System Validation and PQR.
• To prepare impact assessment and risk assessment as or when required.
• To provide support to other sections/departments with respect stability program and any data required for to PQR, Cleaning Validation, and Computer System Validation.
• To review AQR LL, HPR and other quality projects for assessment and actions related to above‑mentioned sections.
• To participate in self‑inspection, Regional, Divisional and AQR Audits as an SME of above‑mentioned sections.
• To implement Audit CAPAs of above‑mentioned sections in timely manner.
• Any other responsibility, assigned by Quality Control Manager or Head of Quality Assurance.
• As an SME support will be provided to Stability Section when required.

Education / Knowledge & Experience

• M.Sc. Chemistry / Pharm-D 8-10 years’ experience in the same capacity.
• Knowledge of requirement for QC/QA activities, Cleaning Validation, Computer System Validation problem resolution skills and other all activities taking place in QC/QA including knowledge of Annual product quality review.
• Knowledge regarding Validation and Facility etc.

Job Family / Division / Location

• JOB FAMILY: Manufacturing
• DIVISION: EPD Established Pharma
• LOCATION: Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, Landhi
• ADDITIONAL LOCATIONS:
• WORK SHIFT: Standard
• TRAVEL: Not specified
• MEDICAL SURVEILLANCE: Not Applicable
• SIGNIFICANT WORK ACTIVITIES: Not Applicable

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.