Production Chemist / Officer – API Manufacturing
- Experience : 1-4 Years
- Qualification : B.Sc / M.Sc (Chemistry)
- Location : Ahmedabad
Job Summary
As a Production Chemist/Officer, you will be responsible for executing batch production activities in compliance with GMP and safety norms. Your role involves monitoring critical process parameters, operating plant equipment, maintaining documentation such as BMRs, and ensuring the production of APIs is carried out efficiently and within quality standards. You’ll work closely with QA/QC teams to meet regulatory expectations and maintain a safe working environment.
Key Responsibilities
- Promote company products to healthcare professionals
- Build and maintain strong relationships with clients
- Achieve monthly and quarterly sales targets
- Ensure accurate and timely reporting
Requirements
- Sound knowledge of API manufacturing operations
- Hands-on experience with equipment like reactors, ANFDs, centrifuges, and dryers
- Familiarity with GMP protocols and shift operations
- Strong safety awareness and documentation skills
Quality Control Executive
- Experience : 1-3 Years
- Qualification : B.Sc / M.Sc (Chemistry)
- Location : Ahmedabad
Job Summary
As a Production Chemist/Officer, you will be responsible for executing batch production activities in compliance with GMP and safety norms. Your role involves monitoring critical process parameters, operating plant equipment, maintaining documentation such as BMRs, and ensuring the production of APIs is carried out efficiently and within quality standards. You’ll work closely with QA/QC teams to meet regulatory expectations and maintain a safe working environment.
Key Responsibilities
- Promote company products to healthcare professionals
- Build and maintain strong relationships with clients
- Achieve monthly and quarterly sales targets
- Ensure accurate and timely reporting
Requirements
- Sound knowledge of API manufacturing operations
- Hands-on experience with equipment like reactors, ANFDs, centrifuges, and dryers
- Familiarity with GMP protocols and shift operations
- Strong safety awareness and documentation skills
R&D Chemist – API Development
- Experience : 1-6 Years
- Qualification : B.Sc / M.Sc (Chemistry)
- Location : Ahmedabad
Job Summary
As a Production Chemist/Officer, you will be responsible for executing batch production activities in compliance with GMP and safety norms. Your role involves monitoring critical process parameters, operating plant equipment, maintaining documentation such as BMRs, and ensuring the production of APIs is carried out efficiently and within quality standards. You’ll work closely with QA/QC teams to meet regulatory expectations and maintain a safe working environment.
Key Responsibilities
- Promote company products to healthcare professionals
- Build and maintain strong relationships with clients
- Achieve monthly and quarterly sales targets
- Ensure accurate and timely reporting
Requirements
- Sound knowledge of API manufacturing operations
- Hands-on experience with equipment like reactors, ANFDs, centrifuges, and dryers
- Familiarity with GMP protocols and shift operations
- Strong safety awareness and documentation skills
Quality Assurance / Regulatory Affairs
Overall Role Objective:
To work as part of the Quality Assurance team at Almac Pharma Service’s Ireland facility in Dundalk, Ireland. The post holder will support the Pharmaceutical Quality System (PQS) and verify the adherence of manufactured products for human use, in line with current Good Manufacturing Practice (cGMP).
JOB SPECIFIC RESPONSIBILITIES:
The following is a non-exhaustive list of responsibilities:
- Utilise a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and Almac procedures, as appropriate.
- Provide quality assurance support/advice to operational departments in support of new and existing projects and products. This will involve interaction with internal and external customers to achieve required timelines while maintaining product quality and compliance.
- Internal/external contact for queries related to product compliance and quality
- Play an active part in the development of the Pharmaceutical Quality System (PQS) by constructively challenging deficiencies and inefficiencies.
- Collate and review data to be used in reports, investigations, key performance indicators (KPIs) and other quality indicating metrics.
- Conduct internal audits as per the approved schedule to detect process and procedural deficiencies. Support the affected areas to ensure appropriate corrective and preventive actions (CAPAs) are undertaken to correct any observations.
- Assist and participate in audits of external suppliers, as well as assist in hosting customer and regulatory audits as required
- Participate in the Supplier Management Process to assure that materials are appropriate for pharmaceutical manufacturing
- Aid as necessary, the life cycle of PQS documentation, such as Deviations, Change Controls, Suspect Analytical Results, Risk Assessments, Technical Agreements, Procedures, Generation, approval and training of new/revised procedures etc.
- Assist in the compilation and review of Product Quality Reviews/ Annual Product Reviews, as appropriate.
- Undertake the review and approval (pre and post-execution) of Master Batch Records (MBRs) and any associated supporting documentation, (such as stability and validation documentation, generation/updating of supply chain maps, compliance dossiers etc), prior to final assessment by a Qualified Person (QP).
- Communicate with internal and external stakeholders regarding projects, products, complaints and other quality related topics, building relationships and trust.
- Monitor and contribute to GMP compliance and Quality of manufactured and released pharmaceutical products
- Additional duties related to the assurance of GMP compliance and quality of manufactured and released pharmaceutical products, may also be assigned. This role may occasionally require coverage beyond normal working hours and infrequent travel. It is a condition of employment that you would be able to fulfil these requirements.
Microbiologist
Major Responsibilities:
Job Summary
The Microbiology Analyst I is responsible for supporting microbiology procedures, assisting in investigations, and performing routine analysis of raw material and finished product according to established specifications and procedures. Essential Duties and Responsibilities include the following. Other duties may be assigned.
product and/or raw materials
- Perform technical review of test results for completeness and compliance to cGMP to ensure that documentation, controls and traceability are in place to maintain integrity
- Prepare and review preparation of media, reagents, test samples and equipment as required
- Prepare microorganisms for identification
- Understand and demonstrate aseptic technique
- Maintain laboratory cleanliness and inventory of microbiology supplies
- Familiar with GxP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice)
- Assist with environmental monitoring and microbiological trend reports
Required Education and Experience
- B.S. degree in Microbiology, Biology or related scientific field
- Minimum 1 year of experience in a microbiology laboratory or pharmaceutical industry
- Knowledge of good analytical and laboratory techniques, GxP, USP and FDA requirements
- Knowledge in statistical data analysis and its application to pharmaceutical or compounding
Processes and quality controls
- Must exhibit good analytical, writing (GDP), interpersonal and organizational skills
- Must be able to meet deadlines
- Must be detail oriented and have multi-tasking capabilities with ability to prioritize
- Must exhibit strong computer skills including but not limited to software packages supporting
statistical data analysis, word processing, and project management programs
- have the ability to work in a fast-paced environment
- exhibit excellent problem resolution skills
- be able to work independently and as part of a team
- exhibit punctuality and low absenteeism
- be able to sit, stand, reach and walk for prolonged periods of time
Eligibility Qualifications
- Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations
- Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) and maintain good personal hygiene (makeup, jewelry and other cosmetics are prohibited from the production areas)
- May be necessary to work extended hours as needed
- May require weekend work
