How To Become An Expert In Pharmaceutical Quality Assurance?

Pharmaceutical Quality Assurance Career Prospectives

Therapeutic manufacturing is one of the well-controlled sectors across the world. To what degree, a drug is ensuring the required cure to patients or assist to defend them in contagious diseases, are all assessed by experts in quality assurance. It serves to assure product efficiency and security in patients, without it, the product will never arrive at the commercialization stage. Lately, there has been a remarkable rise in demand for a few quality assurance professions within pharma production. The greatest cause of this surge is the latest geo-politic incidents and activities by regulatory authorities.

Read further to explore a career in QA and why it could be an apt profession for you.

Pharmaceutical Quality Assurance

Quality Assurance is a key factor in Quality Management. The obligation of experts within QA is to ensure there is no malfunctioning in the entire manufacturing procedure of the drug product.  It’s the duty of Quality Assurance (QA) workers to ascertain that all the goods fulfill the essentials norms and statutes, thereby producing reliable and secure drugs.

Within the therapeutical, medical care, and pharmaceutical tools manufacturers, quality assurance happens during the clinical, development, and marketing cycle of the drug product

. Being an intermediate process along with the action of guaranteeing game-changing instruments or life-saving cure with complete safety makes the role significantly essential

The main liability of QA specialists is the assent and maintenance of documentation, review, and method supervision. Normally QA operations are office-based.

Pharmaceutical Quality Assurance Career in a nutshell

Pharmaceutical Quality Assurance jobs can be either a general or a specified position and are occupied by either in an external agency or in-house. Commonly, individuals transfer from starting roles in health or safety and engineering to QA positions.  

Pharma QA Career path

Scientific qualifications are imperative and lay a strong foundation for a successful career in QA. Clear knowledge and practice in present norms and rules are crucial for sharpening your skill and grabbing QA jobs. Few of them include GMP, GLP, GCP, or ISO standards.

To prosper in your career, you have to build a fine network and learn the activities, production industry thoroughly. Professionals in the pertaining field should be aware of all the recent techniques to be successful in this career.

If an individual is aspiring to advance in their job sector, you’ll require excellent interaction and technological expertise as well as credence in their skills.

Along with this, you’ll need to execute extra roles to transform your career to a top rung

1. Acquire a Degree in a Pertinent Field of Study: This is highly mandatory for this career. In most situations, firms recruit science/ pharma based candidates. Nevertheless, appropriate fields of study range from business admin to chemistry and microbiology.
2. Muster relevant industrial background: Interns beginning their profession will be capable of gathering information and hands-on experience profoundly within a relatively small time period since these candidates will be exposed to operations on CAPA’s, QMS, deviations, risk assessments, root cause, and batch release analysis roles. In addition, they also figure out different rules that come under GxP based on the area, which encompass delivery, clinical and production training. A profession in QA provides exhilarating possibilities for developing and training in fresh areas. This comprises of reviewing (conducting, external, internal, provider, and guiding), QP, and RP training (batch release of a drug product and final conclusion). These are superior tasks, but supplementary training is on offer in few firms to get to this profession, so those who succeed in studying and progression would flourish well in the QA domain.
3. Confidence and communication expertise: To have a bright future in this sector, you must be confident, amiable, and possess good interactive proficiency since you are consistently communicating with outside parties.
4. Adaptability: A vital attribute for a good QA specialist is adaptability. Since you are open to various trades and their commodities, it will be a necessary condition to utilize your initiative and modify your methodology to address encountering issues.

Drug products must follow stringent safety norms and guidelines. Therefore, in order to become an expert in pharma QA, you’ll require a thorough understanding of the subject.

Few topics necessary for pharma QA roles are:

• Post Endorsement Tasks and Conformity
• Pharmaceutical Dissolution Testing
• Pharmaceutical Lab Testing
• HPLC
• Labeling and Drug Product Briefings
• GMP
• Workplace Hazardous Material Information Systems (WHMIS)
• Pharmaceutical Manufacturing Protocols
• Technical Writing and Scientific Communication

Transition possibilities from other QA roles to Pharma QA

If you have a prior experience in QA in any other industry, it is workable to shift to a Pharma QA role, despite the fact that it is essential to comprehend all the stringent norms within the quality.

Due to many comparable factors within QA and regulatory affairs, it is easy to switch between both areas, particularly for small firms. For fresher, it is cardinal to consider that small to moderately functioning organizations provide great opportunity and duties in an entry-level position, which could be a sturdy basis to set. They also present a quick learning environment, progressing possibilities, and career enhancement. Whereas in big firms furnish with faster career growth chances because of large groups, yet exposure level would be reduced to a role within the firm.

Typical Pharmaceutical Quality Assurance Career Progression Options

Ordinary career progression will be in the order of

• Quality Officer
• Senior or Specialist Quality Officer
• QA Manager
• Senior Manager
• Head of Department
• Director
• Vice President

Emoluments for QA professionals

The average salary for a Pharma QA manager in the US is $125,956 a year whereas in India for a QA Pharmaceutical, it is ₹20,823.

Tasks to be performed by Pharmaceutical Quality Assurance Professionals

Pharma QA professionals function in the QA division of a drug manufacturer. They are accountable for assuring that each drug strictly obeys both firm and government standards. They examine each and every stage of production.

QA adepts aid both in developing and screening document control programs, standard operating protocols, and quality systems.  Consequently, a fine understanding of GMPs is mandatory for these experts. You are ideally suited to the role if you have a sharp eye for particular information. For the entire day, you might end up writing protocols to be followed, or examine existing systems to check whether there are any regions for modifications, and even develop a guidebook

Other functions performed by QA workers include:

• Conducting quality reviews
• Developing and enforcing a quality assurance regime
• Guaranteeing that appropriate documentation is drafted
• Disclosing and recording any malfunction in the production procedure

The most demanding jobs in QA:

CAPA Consultant

Pharma enterprises should prioritize patient safety, making CAPA (corrective action and preventive actions) experts in steady demand. CAPA consultant profession encompasses the discovery of the exact reason for the defectiveness. Once the information has been gathered and examined, they will perform the restorative or precautionary action to remove the problem. The function of CAPA is also essential in safeguarding the plant’s quality in sequential advancement. A successful CAPA consultant must be competent, systematic, and have strong logical reasoning skills with an outstanding focus on specifics.

Deviation Investigator

Deviation investigators are probably the most wanted profession, who are research technological experts. This occupation entails verifying and construing deviation occurrences and utilizing their opinion and skill to mention strategies to resolve the issue.  They will help in determining, regulating, and executing CAPAs.

Quality Auditors (GMP)

Quality auditors perform a cardinal role in the manufacturing unit’s output load, assuring they are constantly in huge demand. Quality auditor jobs are primarily associated with devising, performing, and verifying review tasks to guarantee that the production procedures are in abidance with regulator standards and specifications.  They should inform issues and concerns found in reviews to respective superiors. Quality auditors are present to minimize faults and ameliorate the performance to assist firms in progressing for further checking by supreme authorities like FDA.

Validation Engineer

Validation performs an important role in production because it helps safeguard patient safety by assuring manufacturing and quality control instruments, procedures, and technologies according to regulatory standards.

Qualified Person (QP)

A QP is legally liable for guaranteeing that products and manufacturing procedures are entirely compliant, as they finish with each and every product batch. A qualified person must remain calm and confident to provide justified information for doubtful events.

 Quality Assurance Specialist

This role involves operating in association with members of other departments of the organization, to determine and resolve any concerns with the grade of the product. Along with this, these specialists assist to develop and perform protocols in compliance with organizational rules.

Quality Assurance Manager

Quality assurance managers are charged with designing QA standards and actions and regulating and recording quality changes and particular concerns. As managers, they are also accountable for guiding teams, and in some cases, recruiting and teaching new employees.

Quality Assurance Director

These professionals operate directly with R&D groups and engineers to comprehend the functioning of the drug product. They then function with these groups to develop procedures for assuring that all products are rightfully verified and function as proposed. The main objective of this role is to design and control quality and maintain procedures for the achievement of the company.

Top Pharma Companies in India

1. Sun Pharmaceutical Industries Ltd.
2. Dr. Reddys Laboratories Ltd.
3. Divis Laboratories Ltd.
4. Cipla Ltd.
5. Biocon Ltd.
6. Aurobindo Pharma Ltd.

Scope of Pharmaceutical Quality Assurance Career

Quality Assurance (QA) is a very valuable part of the medical industry. Their objective is not only to verify but to offer high-quality outputs. The quality of drug products has been an issue of the WHO. Drug products should be commercialized as safer and therapeutically effective form. Quality control means examining the grade of excellence of drug products and procedures used for production.

Quality assurance is a wide notion. It includes all parameters of your protocol that can have an effect on patients. One academic survey found that QA collapse can result in a considerable amount of money expenditure.  

Concluding remarks

To have a prosperous career within Pharmaceutical Quality Assurance, you will require excellent distinction in the firms and determination to learn. Presenting these vital features, and a robust comprehension of general practices will ace your career.

Pharmaceutical Quality Assurance Career

Author : Geema George